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Tag: Clinical Trial

  • Nutritional epigenetics education reduces ultra-processed food intake in parents of children with autism and ADHD

    Nutritional epigenetics education reduces ultra-processed food intake in parents of children with autism and ADHD

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    In a recent publication released by PubMed, American scientists led by Dr. Dufault at the Food Ingredient and Health Research Institute, reported the results of a clinical trial in which parents who received nutritional epigenetics education significantly reduced their consumption of ultra-processed foods while increasing their intake of whole and/or organic foods. The education intervention used curriculum focused on the constructs of the nutritional epigenetics model that explains how autism and attention deficit/hyperactivity disorder (ADHD) may develop from the excess consumption of ultra-processed foods.

    Consumption of ultra-processed foods leads to heavy metal exposures and dietary deficits that create mineral imbalances such as zinc and calcium losses. Inadequate zinc stores can disrupt the function of the metal transporter metallothionein (MT) gene preventing the elimination of heavy metals found in ultra-processed foods. The bioaccumulation of mercury and/or lead is common in children with autism and ADHD who are often zinc deficient. Mercury, lead, and other heavy metals are known to suppress the paraoxonase (PON1) gene. Paraoxonase is required by the body to detoxify the neurotoxic organophosphate pesticide residues found routinely in the food supply by the United States Department of Agriculture. Children with autism and ADHD are more susceptible to the harmful effects of organophosphate pesticide exposures.

    Parents who received nutritional epigenetics education learned how to reduce their children’s dietary exposures to heavy metal and organophosphate pesticide residues. The parents learned how to read food ingredient labels and changed their diet as they avoided buying foods with allowable heavy metal and pesticide residues. In learning how specific food ingredients contribute to heavy metal exposures, impact nutrient status and/or gene behavior, parents gained the knowledge they needed to feed themselves and their children a healthier diet. By the end of the education intervention, parents had changed their minds about their ability to control their child’s behavior through diet.

    Children behave better when they feel better. Because the severity of symptoms in autism and ADHD correlate directly to the heavy metal levels in blood, children with less heavy metal exposure show improvements in behavior and cognition. In addition, because heavy metals, in single or multi-metallic combination, create conditions for gut dysbiosis, improvements in diet can reduce inflammation and improve gut health. Reducing ultra-processed food consumption can alleviate symptoms associated with gut dysbiosis which is often a co-morbid condition found in children with autism and ADHD.

    Autism and ADHD are preventable, but the prevalence of these neurodevelopmental disorders will continue to increase in the United States until changes are made to reduce the allowable heavy metal residues in the ultra-processed food supply. The US Congress released two reports in 2021 on the problem of heavy metals in baby foods. The first report issued on February 4, 2021, revealed baby foods are tainted with dangerous levels of arsenic, lead, cadmium, and mercury. The second report, issued on September 29, 2021, confirmed new disclosures from manufacturers show dangerous levels of heavy metals in even more baby foods.

    Source:

    Food Ingredient and Health Research Institute

    Journal reference:

    Dufault, R. J., et al. (2024) Nutritional epigenetics education improves diet and attitude of parents of children with autism or attention deficit/hyperactivity disorder. World Journal of Psychiatry. doi.org/10.5498/wjp.v14.i1.159.

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  • Combining clot busters and blood thinners shows no advantage for people with ischemic strokes

    Combining clot busters and blood thinners shows no advantage for people with ischemic strokes

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    Giving blood thinners in addition to clot-busting medications to people with ischemic strokes (clot-caused strokes) did not improve their outcomes 90 days later, according to preliminary late-breaking science presented today at the American Stroke Association’s International Stroke Conference 2024. The meeting, held in person in Phoenix, Feb. 7 – 9, 2024, is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

    These results are from the MOST (Multi-Arm Optimization of Stroke Thrombolysis) trial. MOST is a 57-center U.S. trial that was halted after an independent data and safety board analyzed results on the first 500 patients out of a planned 1,200 participants and determined it highly unlikely that a benefit would be found if the research was completed. The study was looking for improvement in functional outcomes at 90 days.

    When we began the trial, we believed the medications would improve outcomes, so we were surprised with the negative results. However, we designed the trial to allow us to efficiently answer the question for two blood-thinning medications in one trial. We have definitely done that and are pleased with the ability to answer this question.”

    Opeolu M. Adeoye, M.D., M.S., lead author of the study and BJC HealthCare Distinguished Professor of Emergency Medicine and chair of the department of emergency medicine at Washington University School of Medicine in St. Louis, Missouri

    “A lot of our approaches in stroke treatment were learned from how we treat heart attacks. In previous trials, we first tested to make sure these medications were safe for use in stroke and then launched MOST to confirm their safety and test whether they would work to improve functional outcomes and reduce disability after stroke,” Adeoye said.

    The MOST trial enrolled adults with ischemic stroke severe enough that rehabilitation would likely be needed. All participants received a standard clot-busting medication to dissolve the clot (thrombolysis) within three hours of stroke onset. Participants were then randomized to one of three groups for additional treatment: one group received the blood thinner argatroban within 75 minutes of the clot-busting medication, followed by a 12-hour infusion of argatroban. A second group received an initial dose of the blood thinner eptifibatide within 75 minutes of the clot-busting medication, followed by a 2-hour infusion of eptifibatide and a 10-hour infusion of saline placebo. The control group received a clot buster and a placebo treatment (a 12-hour infusion of intravenous saline solution containing neither of the blood-thinning medications).

    The primary outcome was the study participant’s level of physical function at 90 days after ischemic stroke. Physical function levels were assessed using the modified Rankin score, or mRS, a 6-point disability scale. The videotaped assessment was judged by an independent neurologist reviewer who was not aware of which treatment patients had received. The mRS score was translated into a utility-weighted mRS, using validated ratings of functional outcomes by patients and physicians, resulting in a 0 to 10-point scale in which a higher score means a greater benefit from the treatment. The interim analysis was planned at the start of the study and scheduled to take place after 500 patients were enrolled. In addition, a data safety and monitoring board (DSMB) reviewed safety data after every 30 patients enrolled, looking particularly for occurrences of bleeding in the brain.

    In the 514 patients enrolled prior to the trial being halted by the DSMB in July 2023, the analysis found:

    • The two blood thinners used did not significantly increase the risk of bleeding into the brain.
    • However, neither of the two blood thinners improved outcomes in the stroke survivors. On the 0 to 10 utility-weighted mRS scale, patients receiving placebo averaged 6.8, those receiving argatroban averaged 5.2, and those receiving eptifibatide averaged 6.3. (Types of disability will vary, however, people with a utility-weighted mRS scale of 6 are expected to have difficulty performing activities of daily living without assistance or support.)

    Study details and background:

    • The three-arm study was conducted at 57 hospitals in the United States between October 2019 and July 2023.
    • Participants all had ischemic (clot-caused) stroke that rated a 6 or higher on the National Institutes of Health Stroke Severity Scale and considered a moderately severe stroke.
    • 514 adults were enrolled in the trial before it was halted; participants were an average age of 68; about 50% were women; and about 25% identified as Black adults.
    • Participants were treated within three hours after the onset of stroke symptoms (or the last time seen well) using the standard-of-care approach of thrombolysis (delivering clot-busting medications to dissolve the clot).
    • In addition, 44% of the patients across all three groups were treated with interventional removal of their clots called thrombectomy.
    • At the time of enrollment, participants were randomized to receive a blood thinner or placebo within 75 minutes of thrombolysis: 59 received argatroban; 228 received eptifibatide; and 227 received placebo.
    • The primary safety measure was the occurrence of bleeding in the brain (symptomatic intracranial hemorrhage) within 36 hours of receiving one of the two blood thinners. Safety measures were analyzed by the study’s DSMB after every 30 patients were enrolled.

    Medical professionals providing care were aware of whether a blood thinner or placebo were given to each patient. However, neither the patients nor the professionals rating patient outcomes were aware of which patients in any group had received a blood thinner or placebo.

    “In addition, we were not able to address the possible benefit of giving these or similar blood thinners directly into an artery in the area of the stroke, rather than giving the medications systemically through a vein, as done in this trial,” Adeoye said.

    For patients undergoing thrombectomy (mechanical removal of a stroke-causing clot), studies are underway to determine whether delivering blood thinners into the affected artery may improve outcomes.

    The study was conducted at National Institutes of Health StrokeNet sites. StrokeNet was created to conduct small and large clinical trials and research studies to advance acute stroke treatment, stroke prevention and recovery and rehabilitation after a stroke across the lifespan. Other principal investigators were Andrew D. Barreto, M.D., M.S.; Joseph P. Broderick, M.D.; Colin P. Derdeyn, M.D.; Jordan Elm, Ph.D.; and James C. Grotta, M.D. The full list of authors and their disclosures are listed in the abstract.

    All study authors reported funding from the National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health.

    Source:

    American Heart Association

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  • Eleven stroke researchers to be recognized during the 2024 International Stroke Conference

    Eleven stroke researchers to be recognized during the 2024 International Stroke Conference

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    Eleven scientists leading the way in stroke research will be recognized during the American Stroke Association’s International Stroke Conference 2024 for their exceptional professional achievements. The meeting will be held in Phoenix, Feb. 7-9, and is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

    The illustrious group of awardees includes four groundbreaking scientists who have devoted their careers to stroke research and six scientists will be recognized for their notable new research. The awards include the Ralph L. Sacco Outstanding Stroke Research Mentor Award, which honors Ralph L. Sacco, M.D., M.S., FAHA, a past president of the American Heart Association and American Stroke Association, who passed away in January 2023.

    The 2024 honorees are:

    • Bernadette Boden-Albala, M.P.H., Dr.P.H., University of California, Irvine, who will receive the Edgar J. Kenton III Lecture Award.

    • Steven Warach, M.D., Ph.D., Dell Medical School at The University of Texas at Austin, who will receive the David G. Sherman Lecture Award.

    • James F. Meschia, M.D., FAHA, Mayo Clinic in Jacksonville, Florida, who will be honored with the William M. Feinberg Award for Excellence in Clinical Stroke.

    • Marc I. Chimowitz, M.B., Ch.B., Medical University of South Carolina, who will receive the Ralph L. Sacco Outstanding Stroke Research Mentor Award.

    • Louise D. McCullough, M.D., P.H.D., McGovern Medical School at UTHealth Houston, who will be awarded the Thomas Willis Lecture Award.

    • ·Takuma Maeda, M.D., Ph.D., Barrow Neurological Institute in Phoenix, who will receive the Mordecai Y.T. Globus New Investigator Award, for a research abstract.

    • Raed Joundi, M.D., D.Phil., McMaster University in Hamilton, Ontario, Canada, who will receive the Vascular Cognitive Impairment Award for research being presented at the meeting.

    • Oriana Sanchez, M.D., University of Texas, Houston, who will receive this year’s Robert G. Siekert New Investigator Award in Stroke for a research abstract.

    • ·Mohammed Abdelsaid, R.P.H., Ph.D., Mercer University School of Medicine, Savannah, Georgia, who will receive the Stroke Basic Science Award for a research abstract.

    • Shumei Man, M.D., Ph.D., FAHA, Cleveland Clinic in Ohio, who will receive the Stroke Care in Emergency Medicine Award for research being presented at the meeting.

    • Susan Linder, P.T., D.P.T., Ph.D., Cleveland Clinic in Ohio, who will be awarded the Stroke Rehabilitation Award for a research abstract.

    Bernadette Boden-Albala, M.P.H., Dr.P.H., the winner of the Edgar J. Kenton III Lecture Award, is the director and founding dean of the University of California, Irvine’s Program in Public Health and future School of Population and Public Health. With more than two decades of research experience, Boden-Albala is an internationally recognized expert in the social epidemiology of chronic disease whose research has focused on eliminating health disparities through defining and intervening on social support, structural and institutional barriers to optimal health. Her areas of expertise include community-based participatory research, health equity, stroke and cardiometabolic health disparities. She has led numerous large, multi-site studies utilizing community-based participatory research methods in urban and rural communities across the United States and globally, as well as large community health assessment, evaluation, capacity building and workforce training projects. The Edgar J. Kenton III Lecture Award recognizes lifetime contributions to the investigation, management, mentorship and community service in the field of racial and ethnic stroke disparities or related disciplines. Boden-Abala will present her Edgar J. Kenton III lecture, “A Roadmap for Health Equity: Understanding the Importance of Community-Engaged Research,” at 10:18 a.m. MT, Tuesday, Feb. 6.

    Steven Warach, M.D., Ph.D., the recipient of the David G. Sherman Lecture Award, is a professor of neurology at Dell Medical School at The University of Texas at Austin, where he is executive director of the Seton Dell Medical School Stroke Institute and also serves as the regional stroke director for Ascension Texas. Warach is known for his seminal contributions in magnetic resonance imaging of stroke. He earned his Ph.D. in psychology-neuroscience from Michigan State University and M.D. from Harvard Medical School, where he completed his neurology residency. The Sherman Award honors David G. Sherman, M.D., a prominent stroke physician and an internationally recognized leader and researcher in stroke prevention and treatment. The award recognizes lifetime contributions to the investigation, management, mentorship and community service in the stroke field. Warach will present his lecture, “Improving Stroke Diagnosis and Treatment: A Journey Toward the End of Time,“ at 11:32 a.m. MT, Wednesday, Feb. 7.

    James F. Meschia, M.D., FAHA, the awardee of the William M. Feinberg Award for Excellence in Clinical Stroke, is professor of neurology and chair emeritus of the department of neurology at Mayo Clinic in Jacksonville, Florida. Meschia is certified by the American Board of Psychiatry and Neurology (ABPN) in neurology and vascular neurology. Meschia is a pioneer in the study of inherited risk factors for ischemic stroke and has had a longstanding commitment to providing the latest evidence for carotid revascularization as a means for stroke prevention. He was the inaugural medical director of the first Joint Commission-certified stroke center within the Mayo Clinic Foundation, and he has authored or co-authored over four hundred peer-reviewed publications. The William M. Feinberg Award for Excellence in Clinical Stroke is named for the prominent stroke clinician-researcher and American Heart Association volunteer who contributed to a more comprehensive understanding of the causes of stroke. The award recognizes significant contributions to the investigation and management of clinical research in stroke. Meschia’s lecture, “Asymptomatic Carotid Stenosis: Current and Future Considerations,” will be presented at 11:03 a.m. MT, Thursday, Feb. 8.

    Marc I. Chimowitz, M.B., Ch.B., the recipient of the Ralph L. Sacco Outstanding Stroke Research Mentor Award is professor emeritus of neurology at the Medical University of South Carolina in Charleston, South Carolina. His main career interests are in improving treatments for patients with intracranial arterial atherosclerosis and helping to mentor the next generation of clinical and translational scientists.The Ralph L. Sacco Outstanding Stroke Research Mentor Award recognizes outstanding achievements in mentoring future generations of stroke researchers in the field of cerebrovascular disease. Chimowitz will present his lecture, “Mentoring Clinical Stroke Researchers in Challenging Times,” at 11:34 a.m. MT, Thursday, Feb. 8.

    Louise D. McCullough, M.D., P.H.D., FAHA, the winner of the Thomas Willis Lecture Award, is the Roy M. and Phyllis Gough Huffington Distinguished Chair of Neurology at McGovern Medical School; chief of neurology at Memorial Hermann Hospital-Texas Medical Center and co-director of UTHealth Neurosciences, all in Houston. McCullough is a physician-scientist and a practicing vascular neurologist with clinical expertise in sex/gender disparities, the microbiome, stroke and aging, and acute stroke treatments. A renowned investigator, she is well recognized for her work in cerebral vascular disease and is known for her research identifying sex differences in cell death pathways during stroke, which have now been shown to be a major factor in the response to ischemic insult. The Thomas Willis Award recognizes contributions to the investigation and management of stroke basic science. McCullough’s lecture, “Aging, Sex, and Stroke: The Three Amigos of Brain Misadventures,” will be presented at 11:03 a.m. MT, Friday, Feb. 9.

    Takuma Maeda, M.D., Ph.D., the Mordecai Y.T. Globus New Investigator Award in Stroke awardee, is a postdoctoral fellow at Barrow Aneurysm & AVM Research Center (BARRC) at the Barrow Neurological Institute in Phoenix. This award recognizes Globus’ major contributions to research in cerebrovascular disease and his outstanding contributions to the elucidation of the role of neurotransmitters in ischemia and trauma; the interactions among multiple neurotransmitters; mechanisms of hypothermic neuroprotection; and the role of oxygen radical mechanisms and nitric oxide in brain injury. Maeda’s award-winning presentation, Abstract 15, “Pharmacological Activation of Efferocytosis Prevents Intracranial Aneurysm Rupture,” will be presented at 7:30 a.m. MT, Wednesday, Feb. 7.

    Raed Joundi, M.D., D.Phil., is the Vascular Cognitive Impairment Award recipient. He is an assistant professor at McMaster University, an adjunct scientist at the Institute for Clinical Evaluative Sciences (ICES) and an investigator at the Population Health Research Institute, a joint institute of McMaster University and Hamilton Health Sciences, all in Hamilton, Ontario, Canada. The Vascular Cognitive Impairment Award encourages investigators to undertake or continue research or clinical work in the field of vascular cognitive impairment and submit an abstract to the International Stroke Conference. Joundi’ s award-winning presentation, Abstract 67, “Risk and Time-Course of Post-Stroke Dementia: A Population-Wide Cohort Study, 2002-2022,” will be presented at 7:30 a.m. MT, Thursday, Feb. 8.

    Oriana Sanchez, M.D, the winner of the Robert G. Siekert New Investigator Award in Stroke, is currently completing a vascular neurology fellowship in the department of neurology at the University of Texas in Houston. The Siekert New Investigator Award in Stroke recognizes Robert G. Siekert, M.D., who was the founding chairman of the American Heart Association’s International Conference on Stroke and Cerebral Circulation, now known as the International Stroke Conference. The award encourages new investigators to undertake or continue stroke-related research. Sanchez’s award-winning presentation, Abstract 1, “Overcoming Clinical Trial Enrollment Challenges by Monitoring EMS Radio Transmissions: Pre-Hospital Screening of Acute Ischemic Stroke Patients,” will be presented at 7:30 a.m. MT, Wednesday, Feb. 7.

    Mohammed Abdelsaid, R.P.H., Ph.D., the recipient of the Stroke Basic Science Award, is an assistant professor at Mercer University School of Medicine in Savannah, Georgia. The Stroke Basic Science Award recognizes outstanding basic or translational science that is laboratory-based. Abdelsaid’s winning presentation, Abstract 17, “SARS-CoV-2 Spike Protein Exacerbates Thromboembolic Cerebrovascular Complications in Humanized ACE2 Mouse Model,” will be presented at 7:54 a.m. MT, Wednesday, Feb. 7.

    Shumei Man M.D., Ph.D., FAHA, the Stroke Care in Emergency Medicine Award awardee, is a neurologist at the Cleveland Clinic and stroke center director of Cleveland Clinic Fairview Hospital in Ohio. The Stroke Care in Emergency Medicine Award encourages investigators to undertake or continue research in the emergent phase of acute stroke treatment and submit an abstract to the International Stroke Conference. Man’s winning presentation, Abstract 43, “Race-Ethnic Specific Trends in Stroke Thrombolysis Care Metrics in Relation to U.S. Target: Stroke Nationwide Quality Improvement Program 2003-2021,” will be presented at 2:00 p.m. MT, Wednesday, Feb. 7.

    Susan Linder P.T., D.P.T., Ph.D., the Stroke Rehabilitation Award recipient, is director of clinical research for the department of physical medicine and rehabilitation at the Cleveland Clinic in Ohio. The Stroke Rehabilitation Award encourages investigators to undertake or continue research and/or clinical work in the field of stroke rehabilitation. Linder’s winning presentation, Abstract TMP28, “Forced-Rate Aerobic Cycling Enhances Motor Recovery in Persons With Chronic Stroke: A Randomized Clinical Trial,” will be presented at 6:15 p.m. MT, Thursday, Feb. 8.

    Source:

    American Heart Association

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  • New weight loss drug may be an effective strategy for preventing or treating high blood pressure

    New weight loss drug may be an effective strategy for preventing or treating high blood pressure

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    The new weight loss medication tirzepatide significantly lowered the systolic blood pressure (the top number in a blood pressure reading) for nearly 500 adults with obesity who took the medication for about eight months, according to new research published today in Hypertension, an American Heart Association journal.

    Systolic blood pressure, or the top number in the blood pressure reading, is a stronger predictor for cardiovascular death than diastolic, or bottom number, blood pressure. According to the American Heart Association’s 2024 Heart Disease and Stroke Statistics, more than 122 million adults in the United States, or 47% of adults have hypertension, and nearly 42% of adults have obesity.

    Tirzepatide works by mimicking two metabolic hormones in the body: it acts as a glucagon-like peptide-1 (GLP-1) receptor agonist and also as a glucose dependent insulinotropic polypeptide (GIP) receptor agonist. These hormones stimulate insulin secretion and sensitivity after a person eats. Together, they have been found so far to help regulate the body’s blood sugar levels, slow down digestion and reduce appetite, which makes a person feel more full and eat less, leading to weight loss. In contrast, semaglutide has only the GLP-1 hormone; it does not contain a GIP receptor agonist.

    In 2022, the Food and Drug Administration approved tirzepatide for prescription as a treatment for Type 2 diabetes. In late 2023, the FDA also approved it for chronic weight management for people with obesity (body mass index of 30 kg/m2 or higher) or overweight (body mass index of 27-29 kg/m2) and at least one weight-related health condition, such as high blood pressure, Type 2 diabetes or high cholesterol.

     “Our findings indicate treating obesity with the weight loss medication tirzepatide may be an effective strategy for preventing or treating high blood pressure,” said lead study author James A. de Lemos, M.D., FAHA, the Kern Wildenthal, M.D., Ph.D., distinguished chair of cardiology and a professor of medicine at UT Southwestern Medical Center in Dallas. “Although tirzepatide has been studied as a weight loss medication, the blood pressure reduction in our patients in this study was impressive. While it is not known if the impact on blood pressure was due to the medication or the participants’ weight loss, the lower blood pressure measures seen with tirzepatide rivaled what is seen for many hypertension medications.”

    The current research was a planned sub-study including 600 of the participants from the SURMOUNT-1 weight loss study to determine if there was an effect on blood pressure. The sub-study was designed to assess the effects of tirzepatide on blood pressure levels as measured by 24-hour ambulatory blood pressure monitoring in people with obesity but without Type 2 diabetes.

    Participants received either a placebo or a dose of tirzepatide in one of three strengths (5 mg, 10 mg or 15 mg). About one-third of participants reported they had high blood pressure at the beginning of the study and were taking one or more hypertension medications. When the sub-study began, all of the participants had blood pressure levels that were less than 140/90 mm Hg, and if they used blood pressure medications, they were required to have been taking their blood pressure medications for at least three months. The sub-study included participants who had hypertension and who had normal blood pressure.

    The study was conducted from December 2019 to April 2022, and the participant results after 36 weeks of taking tirzepatide indicate:

    • For participants taking 5 mg of tirzepatide, there was an average reduction in systolic blood pressure of 7.4 mm Hg.

    • For participants taking 10 mg of tirzepatide, there was an average reduction in systolic blood pressure of 10.6 mmHg.

    • For participants taking 15 mg of tirzepatide, there was an average reduction in systolic blood pressure of 8.0 mm Hg.

    • The blood-pressure lowering effects of tirzepatide were evident in blood pressure measures taken during both the day and night. Nighttime systolic blood pressure is a stronger predictor for cardiovascular death and all-cause death than daytime blood pressure readings.

    The reductions in systolic blood pressure were consistent across subgroups of participants in the study who were categorized by additional factors, including age, sex, body mass index and hypertension-related risk factors.

    Study background and details:

    • SURMOUNT-1 was a randomized study on the effect of increasing doses of tirzepatide on weight loss. It found that in participants with overweight or obesity (body mass index (BMI) ≥27 kg/m2), once-weekly injections of 5 mg, 10 mg or 15 mg of tirzepatide led to mean weight reductions of 15%, 19.5% and 20.9%, respectively, compared to placebo.

    • The sub-study included 600 adults from SURMOUNT-1: 155 participants received placebo; 145 were taking tirzepatide 5 mg; 152 were taking tirzepatide 10 mg; and 148 were taking tirzepatide 15 mg.

    • Blood pressure measurements were available and analyzed for 494 participants who valid ambulatory blood pressure monitoring data at the beginning of the study and at week 36.

    • Only the study participants with at least 70% valid readings on ambulatory monitoring and a minimum of 20 daytime and seven nighttime readings were included in the data analyses. This was 494 out of 600 initial participants.

    • 69% of study participants self-identified as female, and 31% self-identified as male. 66.8% self-identified as white adults, 11.8% self-identified as Black adults and 25% self-identified as Hispanic ethnicity.

    • The average age of the participants was 45.5 years, and their average BMI was 37.4 kg/m2, which meets the criteria for obesity (obesity is BMI≥30). People with obesity have an increased risk of high blood pressure, heart disease, stroke and Type 2 diabetes, as well as other health conditions.

    • Ambulatory blood pressure monitoring used in this study included blood pressure measurements every 30 minutes during the day and every hour at night, providing a more comprehensive assessment of blood pressure than in office or daily home blood pressure measurements. For ambulatory blood pressure monitoring, study participants wore a blood pressure monitoring device for a 24- to 27-hour period that measured blood pressure throughout waking and sleeping hours. Ambulatory blood pressure monitoring was conducted when participants first began taking tirzepatide at the start of the study and after 36 weeks of being enrolled in the study.

    The 2017 ACC/AHA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults classifies hypertension, or high blood pressure, as having top and bottom blood pressure measures greater than or equal to 130/80 mm Hg. 

    Study limitations include that it was only conducted in a subset of the original 2,539 SURMOUNT-1 participants; the ambulatory blood pressure monitoring was only measured at two points in the study -; baseline and at 36 weeks; and measurements were only taken once per hour at night to minimize the burden on study participants. In addition, changes in food intake and 24-hour urine sodium excretion were not assessed, meaning the contribution of dietary modifications including salt intake or other changes that may help to reduce blood pressure are unknown and cannot be estimated.

    “Overall, these data are encouraging that novel weight-loss medications are effective at reducing body weight and they are also effective at improving many of the cardiometabolic complications of obesity including hypertension, Type 2 diabetes and dyslipidemia, among others. While the impact of each of these beneficial effects is individually important, many of these obesity-related complications act synergistically to increase the risk of cardiovascular disease. Thus, strategies that mitigate multiple obesity-related complications may reduce the risk of cardiovascular events,” said Michael E. Hall, M.D., M.S., FAHA, chair of the writing group for the Association’s 2021 scientific statement on weight-loss strategies for prevention and treatment of hypertension and chair of the department of medicine at the University of Mississippi Medical Center in Jackson, Mississippi.

    Additional studies will be necessary to determine the long-term impact on cardiovascular events such as heart attack and heart failure. Also, studies are needed to investigate what happens to blood pressure when medications like tirzepatide are discontinued – does the blood pressure rebound and go back up, or does it remain lowered?”


    Michael E. Hall, M.D., M.S., FAHA, chair of the writing group

    Co-authors and disclosures are listed in the manuscript. The study was funded by Eli Lilly and Company, the manufacturer of tirzepatide.

    Source:

    American Heart Association

    Journal reference:

    de Lemos, J. A., et al. (2024) Tirzepatide Reduces 24-Hour Ambulatory Blood Pressure in Adults With Body Mass Index ≥27 kg/m2: SURMOUNT-1 Ambulatory Blood Pressure Monitoring Substudy. Hypertension. doi.org/10.1161/HYPERTENSIONAHA.123.22022.

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  • First gene therapy trial aims to restore hearing in children

    First gene therapy trial aims to restore hearing in children

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    The aim of this clinical trial, which has just received approval in France, is to assess the safety and efficacy of a new gene therapy drug in children aged between 6 and 31 months with profound hearing loss. Audiogene was developed by a French consortium composed of teams from the Hearing Institute, an Institut Pasteur research center; the ENT Department and Pediatric Audiology Research Center at Necker-Enfants Malades Hospital (AP-HP); Sensorion and Fondation Pour l’Audition. The trial has also been submitted to other European countries and is currently undergoing assessment.

    Audiogene is the first clinical trial in France to test a gene therapy drug, SENS-501, developed by the biotech company Sensorion, to treat children with DFNB9, a form of hereditary deafness caused by mutations in the OTOF gene, which encodes a protein called otoferlin. The usual treatment for this form of hearing loss is a bilateral cochlear implant.

    The aim of this treatment is to restore hearing. It works by injecting a copy of the normal otoferlin gene into the child’s impaired inner ear. The SENS-501 drug is designed to correct the genetic abnormality in the inner ear cells of children with hearing loss and restore inner ear cell function and hearing in these children.

    The first step in the clinical trial will be to test two doses of SENS-501 so that the optimal dose can be selected for the rest of the trial.

    In practice, the SENS-501 gene therapy drug will be directly injected into the inner ear of the child with DFNB9 deafness. The drug is injected into the round window in the inner ear, in a similar way to cochlear implantation surgery. The procedure will be performed under general anesthetic by a lead ENT surgeon. The drug will be administered using an injection system developed in partnership with the company EVEON, so that the injected dose can be measured precisely and the inner ear structures can be preserved.

    This gene therapy for hearing loss patients with an otoferlin deficiency was developed as part of the RHU AUDINNOVE project, involving a consortium composed of scientists from the Hearing Institute, an Institut Pasteur research center; physicians from the ENT Department and Pediatric Audiology Research Center at Necker-Enfants Malades Hospital (AP-HP); and teams from Sensorion and Fondation Pour l’Audition.

    A collective effort that thrills the AUDINNOVE stakeholders

    The launch of the Audiogene clinical trial is a major step forward for deaf children with otoferlin defects and their parents but also brings hope to people with genetic deafness. We are very proud that our long-time support to French innovation and to the teams of Prof. Petit at the Hearing Institute, an Institut Pasteur research center, and Prof. Loundon, at the Clinical Center for Research in Pediatric Audiology at AP-HP Necker hospital, translates now into a trial.”


    Denis Le Squer, Executive Director of Fondation Pour l’Audition

    Alain Chédotal, Chair of the Scientific Committee at Fondation Pour l’Audition: “The launch of the first gene therapy clinical trial for a deafness in France is a major milestone for Fondation Pour l’Audition, which supported the project from its beginning. It embodies our high-level scientific and medical actions and positions France as a key player in this field at an international level. It also embraces our strong ambition to speed up the development of therapies for individuals with hearing disorders.”

    Nawal Ouzren, Chief Executive Officer of Sensorion, said: “The launch of the Audiogene clinical trial is a significant milestone in the development program of SENS-501, a pioneering drug candidate in the field of gene therapies for genetic hearing loss. We are delighted to be continuing our collaboration with the team at the Fondation Pour l’Audition, the research teams at the Hearing Institute and the clinical team at the Pediatric Audiology Research Center at Necker-Enfants Malades Hospital (AP-HP), as part of the AUDINNOVE consortium. This consortium, composed of leading stakeholders, is currently one of the few players worldwide capable of bringing about a technological and medical revolution that offers real hope for all children with congenital hearing loss.”

    Natalie Loundon, Director of the Pediatric Audiology Research Center and a Pediatric Otolaryngologist and Head and Neck Surgeon at Necker-Enfants Malades Hospital (AP-HP), who is the Audiogene clinical trial coordinator investigator, comments: “This project is incredibly innovative and represents a first in the field, raising high hopes for patients with hearing loss. The project heralds the advent of a revolution in the future treatment of hearing loss patients. For this study, DFNB9 patients will be offered an alternative to cochlear implantation. We are already working on widening the indications to include other causes of hearing loss.”

    Christine Petit, Professor at the Institut Pasteur and Professor Emeritus at the Collège de France, added: “This clinical trial, which aims to correct the deficiency in a gene responsible for congenital hearing loss to restore hearing, is based on the pioneering research carried out at the Institut Pasteur in our Genetics and Physiology of Hearing Unit, which involved identifying the genes responsible, elucidating the defective mechanisms and demonstrating the possible reversal of hearing loss in the laboratory. We have been performing research on DFNB9 deafness for around 20 years now. Audiogene assembles a wide range of expertise so that these discoveries can be applied for the benefit of people with hearing loss. There is currently no treatment for hearing loss. The success of this clinical trial should serve as a catalyst in the search for much-needed therapeutic solutions for a whole series of hearing impairments and vestibular disorders.”

    Anne-Lise Giraud, Director of the Hearing Institute, an Institut Pasteur center, concluded: “The Hearing Institute is delighted with this major first, to which its teams, especially those led by Christine Petit and Saaid Safieddine, have made a huge contribution by paving the way for the translation of basic research into therapeutic applications.”

    Multiple technological innovations

    A gene can only enter inner ear cells if it is transported by a viral vector that is capable of crossing the cell membrane. In this case the adeno-associated virus (AAV) is used to deliver the gene. As the OTOF gene is so big, it is divided into two DNA fragments, each transported by an AAV, which are then assembled inside the inner ear cells. This is referred to as a dual AAV vector technology. AAV vectors are harmless and non-pathogenic; they are reliable, well known and do not cause diseases. They are produced using the highest applicable industry standards and approved by health authorities for use in humans. Some are already in use and have been marketed as treatments.

    This work was supported by the French National Research Agency which is funding the France 2030 program entitled RHU AUDINNOVE, ANR-18-RHUS-0007.

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  • Lentils lower cholesterol and sugar response, study finds

    Lentils lower cholesterol and sugar response, study finds

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    In a recent article published in the journal Nutrients, researchers evaluate the impact of 12 weeks of regular lentil consumption on metabolic health. 

    Study: Twelve Weeks of Daily Lentil Consumption Improves Fasting Cholesterol and Postprandial Glucose and Inflammatory Responses—A Randomized Clinical Trial. Image Credit: Gulcin Ragiboglu / Shutterstock.com Study: Twelve Weeks of Daily Lentil Consumption Improves Fasting Cholesterol and Postprandial Glucose and Inflammatory Responses—A Randomized Clinical Trial. Image Credit: Gulcin Ragiboglu / Shutterstock.com

    The health benefits of lentils

    The United States Department of Agriculture (USDA) recommends that adults consume about 300 grams of cooked pulses weekly. Lentils, a type of pulse, are known for their high dietary fiber and protein content, as well as the presence of certain bioactive compounds like polyphenols.

    To date, few studies have investigated the long-term impact of lentil consumption at the USDA-recommended dose. Moreover, pulse intervention studies have rarely evaluated the gastrointestinal (GI) symptoms that may arise in response to pulse consumption.

    About the study

    The present randomized clinical trial assessed dynamic lipidemic, glycemic, and inflammation responses during a 12-week dietary intervention of seven midday meals totaling 980 or zero grams of cooked green lentils every week on the health of 18-70-year-olds at a greater risk of developing chronic metabolic disorders.

    Included males and females had a waist circumference of 40 or 35 inches or more, respectively, as this is an accepted proxy for central adiposity. Furthermore, all study participants had non-fasting serum triglyceride (TG) levels exceeding 1.69 mmol/L or 150 mg/dL. 

    Surveys were administered once a week to assess how lentil consumption impacted GI symptoms and satiety throughout the 12-week intervention. At baseline, anthropometric measurements and each participant’s written consent were obtained.

    Habitual dietary patterns and specific diet components were also reported to detect differences between meal groups. At visit two, postprandial serum TG levels were measured to ensure that the study participants continually met the inclusion criteria.

    During the 12-week dietary intervention period, study participants were asked to complete a high-fat meal challenge, wherein they consumed a 50-gram oral fat load. Blood samples were collected after fasting and hourly for five hours postprandially for blood marker assessment. 

    General linear models were used to assess physical and biological changes across both groups from pre- to post-intervention. Linear mixed-effects models were used to determine the impact of timing and meals on satiety measures and GI symptom severity.

    Study findings

    A total of 38 overweight and obese adults with a mean age of 47.2 years and body mass index (BMI) of 34.4 kg/m2 completed the 12-week intervention. From pre- to post-intervention, anthropometric metrics did not change in either meal group.

    Throughout the study period, total fiber consumption averaged 17.3 g and 22.9 g in the lentil and control groups, respectively. While sodium intake increased among lentil consumers, dairy and refined grain consumption decreased among controls.

    For lentil recipients, daily average legume consumption significantly increased from baseline at 0.1 to 0.6 cups, which increased their Healthy Eating Index (HEI) scores in four domains. Those who consumed lentils also had higher total, insoluble, and soluble fiber intake.

    The mean response rates to the satiety and GI surveys were 89.6 and 90.8% for the control group, respectively, and 89% and 89.4% for the lentil group, respectively. While satiety measures did not vary by meal groups, GI symptom severity responses for both groups were rated as none or mild among 87.7%, with only 10% and 2.3% rating them as moderate or severe, respectively, throughout the 12-week intervention.

    Twelve weeks of daily lentil consumption decreased fasting measures of lipid metabolism, including total and low-density lipoprotein (LDL) cholesterol levels. In addition, long-term lentil consumption improved postprandial glucose and inflammation responses to a high-fat meal challenge. 

    A potential explanation for this observation is that fiber binds bile acids, thereby preventing their return to the liver and stimulating the production of hepatic bile acids. The body replenishes hepatic cholesterol levels through cholesterol uptake from the blood, which decreases serum cholesterol levels.

    Another mechanism by which lentils likely helped reduce serum cholesterol is through saponins, which are bioactive compounds that regulate lipid metabolism and prevent cholesterol absorption. Habitual lentil consumption could also lower total saturated fat intake, a diet component that increases cholesterol levels. 

    Conclusions

    The study findings indicate that 12 weeks of lentil consumption in individuals at a higher risk of developing metabolic disease could reduce fasting cholesterol levels, as well as improve postprandial glucose and systemic inflammatory responses.  

    Lentil consumption exceeding the USDA recommended dose did not cause GI distress. Importantly, these metabolic improvements were independent of changes in anthropometric measures, thus suggesting a direct impact of lentil consumption on metabolism.

    Thus, increased lentil consumption could be a safe and effective dietary strategy to improve metabolic health in high-risk populations. Future studies are needed to investigate the impact of prolonged consumption of other pulses on metabolic health.

    Journal reference:

    • Chamberlin, M. L., Wilson, S. M., Gaston, M. E., et al. (2023). Twelve Weeks of Daily Lentil Consumption Improves Fasting Cholesterol and Postprandial Glucose and Inflammatory Responses—A Randomized Clinical Trial. Nutrients 16(3); 419. doi:10.3390/nu16030419

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  • New vaccine may be potential off-the-shelf treatment for pancreatic, colorectal cancer

    New vaccine may be potential off-the-shelf treatment for pancreatic, colorectal cancer

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    A new vaccine shows encouraging early results as a potential off-the-shelf treatment for certain patients with pancreatic or colorectal cancer, according to a study co-led by researchers at Memorial Sloan Kettering Cancer Center (MSK). The vaccine targets tumors with mutations (or changes) in the KRAS gene, a driving force in many cancers.

    This cancer vaccine is different from another type of pancreatic cancer vaccine, which is custom-made for each patient using messenger RNA (mRNA). Both are therapeutic vaccines given after surgery to prevent or delay the cancer from coming back in high-risk patients.

    “Having a vaccine that’s ‘off-the-shelf’ would make it easier, faster, and less expensive to treat a larger number of patients,” says medical oncologist and pancreatic cancer specialist Eileen O’Reilly, MD, who helped lead the trial and is one of the corresponding authors in the study published in Nature Medicine. “This gives hope for people with pancreatic and colorectal cancer who have been out of effective treatments when their disease returns.”

    Dr. O’Reilly is co-corresponding author of the Nature Medicine study, along with Shubham Pant, MD, of MD Anderson Cancer Center, and Christopher M. Haqq, MD, PhD, of Elicio Therapeutics.

    Clinical trial results for pancreatic and colorectal cancer KRAS vaccine

    The phase 1 trial involved 25 patients whose pancreatic or colorectal cancer had certain KRAS mutations and were at high risk of the cancer returning after surgery. The results demonstrated this vaccine is safe and appears to stimulate the patient’s immune system to create cancer-fighting cells:

    • 84% of patients had the desired immune response, meaning that immune T cells targeting KRAS-mutated cancer cells were activated and grew in number.

    • Also in 84% of patients, a marker for lingering cancer cells -; the amount of tumor DNA circulating in the blood -; was reduced. In 24% of patients, the tumor DNA was completely absent.

    • Perhaps most significant, patients who had a higher T cell response also experienced a longer time without the disease returning, known as relapse-free survival.

    In patients whose immune system appeared to respond to the vaccine, the recurrence of cancer was delayed compared with patients who did not respond to the vaccine. That’s the type of early clinical effect we can build on.”


    Eileen O’Reilly, MD, medical oncologist and pancreatic cancer specialist

    How off-the-shelf vaccines targeting KRAS mutations differ from personalized mRNA vaccines

    A different approach to activating immune cells has been led by surgical oncologist Vinod Balachandran, MD. He is investigating whether a personalized mRNA vaccine using proteins from a patient’s pancreatic tumors will alert their immune system that the cancer cells are foreign. In this way, the mRNA vaccine trains the body to protect itself against cancer cells. This vaccine is now being tested in a phase 2 research study at MSK and other institutions.

    Personalized vaccines -; while promising -; also have challenges. They take time to make and are costly. By contrast, an off-the-shelf vaccine manufactured in batches could be given to patients with minimal delay and would be cheaper to produce.

    “These findings are exciting because they show we may have more than one way to activate immune cells to target pancreatic cancer,” Dr. O’Reilly says.

    Source:

    Memorial Sloan Kettering Cancer Center

    Journal reference:

    Pant, S., et al. (2024). Lymph-node-targeted, mKRAS-specific amphiphile vaccine in pancreatic and colorectal cancer: the phase 1 AMPLIFY-201 trial. Nature Medicine. doi.org/10.1038/s41591-023-02760-3.

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  • Sleeve gastrectomy vs. Roux-en-Y gastric bypass

    Sleeve gastrectomy vs. Roux-en-Y gastric bypass

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    A recent study published in JAMA Network Open evaluates the differences in perioperative outcomes between laparoscopic sleeve gastrectomy (SG) and laparoscopic Roux-en-Y gastric bypass (RYGB).

    Study: Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass: A Randomized Clinical Trial. Image Credit: Donenko Oleksii / Shutterstock.comStudy: Comparison of Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass: A Randomized Clinical Trial. Image Credit: Donenko Oleksii / Shutterstock.com

    Background

    The worldwide prevalence of obesity has increased substantially, with many studies indicating that this metabolic disorder is associated with significant mortality. Individuals with severe obesity may undergo metabolic and bariatric surgery, which is otherwise known as weight loss surgery, for weight management.

    Although SG and RYGB are the most commonly performed surgical bariatric procedures, no studies have compared their safety and effectiveness. Until 2017, the most widely performed bariatric surgical procedure was RYGB in Sweden, until it ultimately shifted to SG.  

    RYGB has been associated with providing sustained weight loss and improvements in overweight-related comorbidities; however, this procedure is associated with an increased risk of abdominal pain, small bowel obstruction, nutritional deficiencies, alcohol use disorder, and post-bariatric hypoglycemia 

    European randomized clinical trials have compared SG and RYGB and revealed no significant differences in weight loss and resolution of comorbidities between the two procedures. Although diabetic patients who underwent RYGB exhibited better glucose control than those subjected to SG, these findings are based on limited-size clinical trials. 

    About the study

    The current randomized and large-scale clinical trial compared the effectiveness of SG and RYGB in weight loss and risk to adverse events to determine which weight reduction surgical technique is more efficient. This study is extremely important due to the sudden increase in SG procedures in Sweden and Norway.

    Perioperative outcomes of SG and RYGB, based on a large Swedish and Norwegian randomized clinical trial, were presented. A previously published Bypass Equipoise Sleeve Trial (BEST) methodology was followed, which was a multicenter randomized clinical trial that assessed the five-year outcomes of SG and RYGB.

    Perioperative outcomes were measured between zero and 30 days of SG and RYGB, along with 90-day mortality. The study cohort included individuals 18 and older with a body mass index (BMI) between 35 and 50.

    All study participants were recommended bariatric surgery. Participants with inflammatory bowel disease, uncontrolled psychiatric disease, moderate to severe gastroesophageal reflux disease, under-substance use, and those with a history of major upper gastrointestinal tract surgery were excluded. Eligible participants were randomly selected for SG or RYGB.

    Study findings

    A total of 878 and 857 patients underwent SG and RYGB, respectively, in twenty-three hospitals. The study cohort consisted of 74% females and 26% males, and their average age was 42.9 years, with a mean BMI of 40.8. 

    A low rate of perioperative complications was observed in both groups without statistical significance. Although aSG was associated with  lower perioperative risk than RYGB, this was not considered clinically relevant due to the existence of other comorbid factors and differential long-term weight control efforts.

    A higher number of serious adverse events within 30 days of the procedure was observed in the RYGB group in comparison to the SG group. In randomized studies, a more significant risk difference between groups could be due to selection bias, as healthier patients are more likely to undergo SG. 

    Contradictory study outcomes are also affected by the nature of the cohort. For example, the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) study included patients with higher BMI and comorbidities than BEST. Therefore, MBSAQIP was associated with more complicated surgical procedures than BEST. 

    The BEST data reflects the possibility that a surgical community with a wider experience of performing RYGB can swiftly shift to SG with low complication rates. However, the possibility of an opposite transition must be reviewed.

    As compared to previous assessments on perioperative complications after RYGB, the current study observed small bowel obstruction to be the most common perioperative complication. A higher incidence of small bowel obstruction after RYGB could be linked with the Lönroth surgical technique for RYGB.

    The operating time between RYGB and SG was compared, in which a greater operating time was associated with RYGB, which could be due to the greater complexity of this surgical procedure. In both SG and RYGB, the length of post-operative hospitalization was one day after surgery.

    Conclusions

    The current randomized and large-scale observational study assessed the outcomes of SG and RYGB in individuals with a BMI of 35 to 50. Both surgical procedures were associated with low and insignificantly different perioperative morbidity. The study highlighted that perioperative risk should not be considered a criterion for selecting between SG and RYGB procedures.

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  • Nerve stimulation plus physical rehabilitation may boost recovery of arm and hand function

    Nerve stimulation plus physical rehabilitation may boost recovery of arm and hand function

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    Combining brain stimulation with intense physical rehabilitation helped stroke survivors recover movement in their arms and hands and maintain these improvements for one year, according to a study to be presented at the American Stroke Association’s International Stroke Conference 2024. The meeting will be held in Phoenix, Feb. 7-9, and is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

    The recovery of arm and hand function after a stroke often stalls or even declines, leaving many patients with chronic motor deficits that limit their independence and quality of life. New treatments that can boost the benefits of physical rehabilitation are desperately needed.”


    Teresa J. Kimberley, Ph.D., study’s lead author, professor of rehabilitation science and physical therapy at MGH Institute of Health Professions in Boston

    Vagus nerve stimulation is the first approved neuromodulation device to aid in chronic stroke recovery. It was approved by the U.S. Food and Drug Administration in 2021 to treat moderate to severe upper extremity motor function deficits (physical movement and coordination of arms and hands) associated with chronic stroke.

    “This is the first time that brain stimulation combined with rehabilitation therapy for stroke is available outside of a clinical trial. It could set the stage for even more advancements in recovery from other impairments beyond the arm,” Kimberley said. “This is a watershed moment for rehabilitation science.”

    This study represents one-year outcomes in the VNS-REHAB pivotal trial, which studied people who had a stroke resulting in moderate to severe upper extremity impairment.

    Two groups of participants (108 total people) -; a control group and an experimental group -; completed six weeks of in-clinic, intense rehabilitation paired with active or sham vagus nerve stimulation. All participants were implanted with the nerve stimulation device and then randomized to receive either real nerve stimulation or a sham stimulation that only turned on for a few pulses. The in-clinic therapy was followed by a three-month home exercise program for both groups. The active vagus nerve stimulation group continued the home exercise program for a year. After the six-week period of sham stimulation, the control group crossed over and received six weeks of active vagus nerve stimulation followed by a year of the home exercise program.

    Before and after the stimulation and rehabilitation therapies, motor function was assessed with the Fugl-Meyer Assessment-Upper Extremity, which assesses motor impairment, and the Wolf Motor Function Test, which is a time-based method to evaluate upper extremity motor ability while providing a better understanding of joint-specific and total limb movements.

    The final study results represent outcomes for arm and hand function in 74 stroke survivors after one year of physical rehabilitation treatment. Data was unavailable for the remaining 34 participants mainly due to the COVID-19 pandemic.

    This analysis found:

    • At one-year, upper limb function improved by 5.3 points in the Fugl-Meyer Assessment-Upper Extremity and by 0.51 points in the Wolf Motor Function Test when compared to baseline.

    • Vagus nerve stimulation therapy improved hand and arm function by 2-3 times more than intense rehabilitation alone.

    “The pairing of rehabilitation therapy with vagus nerve stimulation likely helps the brain strengthen new neural pathways – like building a bridge to bypass a damaged area,” Kimberley said.

    “These long-term, pivotal results mirror our long-term results from an earlier pilot study where we found that patients continue to improve or maintain their gains up to three years after starting vagus nerve stimulation therapy paired with rehabilitation,” she said. “As a clinician, it is surprising to see someone with chronic stroke – stroke that in many ways is a progressive disease – continue to improve and not show a decline.”

    Study details and background:

    • The vagus nerve stimulation device in this study included a pacemaker connected to a lead that wraps around the vagus nerve in the neck region. There’s one vagus nerve on each side of the body; each one runs from the lower part of the brain through the neck to the chest and stomach.

    • VNS-REHAB trial participants were between the ages of 22-80 and had a stroke nine months to 10 years prior to study enrollment.

    • Study participants in the experimental group were 64% male and 36% female; 79% white, 17% African American adults, 2% Asian, Indian or other adults, and 1% did not have any race reported. The control group was 65% male and 35% female; 78% white, 16% African American adults, 7% Asian, Indian or other adults, and 1% did not have any race reported.

    • The study took five years to complete: 2017-2019 for enrollment, and the study ended in 2021.

    • The study was triple-blinded, meaning neither the participants, the researchers testing participants nor the health care professionals treating participants knew which intervention group participants were in.

    Study limitations included the small sample size and lack of details about the rehabilitation therapy regimens followed by each participant over the one-year period, which were variable.

    Future studies and an ongoing clinical registry will explore the long-term impact of active vagus nerve stimulation in real-world settings.

    “Often after a stroke, people don’t seek additional treatment, thinking that their current impairments are permanent. This is not true! Paired vagus nerve stimulation opens a new avenue and new hope for these patients. I’m also excited about future research that will investigate vagus nerve stimulation paired with rehabilitation for other conditions, such as gait and speech impairments after stroke,” Kimberley said.

    “These are encouraging findings,” said Joel Stein, M.D., FAHA, chair of the writing group for the American Heart Association’s/American Stroke Association’s 2021 Clinical Performance Measures for Stroke Rehabilitation and the Simon Baruch Professor and chair of the department of rehabilitation and regenerative medicine at Columbia University’s Vagelos College of Physicians and Surgeons; professor and chair of the department of rehabilitation medicine at Weill Cornell Medicine; and physiatrist-in-chief at NewYork-Presbyterian Hospital. “These results demonstrate the durability of the effects of vagus nerve stimulation, an important finding that supports the use of this modality to enhance recovery post-stroke. There is some evidence for lasting improvement with continued use outside of a formal exercise program, which is intriguing, although further research is needed to confirm this finding and clarify who is likely to experience ongoing improvements.” Dr. Stein was not involved in this study.

    Source:

    American Heart Association

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  • Stroke survivors in gym-rich neighborhoods more likely to stay physically active

    Stroke survivors in gym-rich neighborhoods more likely to stay physically active

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    Stroke survivors were more likely to remain physically active or even exercise more after their stroke if they lived in neighborhoods with easy access to recreational centers and gyms, according to a preliminary study to be presented at the American Stroke Association’s International Stroke Conference 2024. The meeting will be held in Phoenix, Feb. 7-9, and is a world premier meeting for researchers and clinicians dedicated to the science of stroke and brain health.

    We know that stroke survivors need to be physically active as part of their recovery. Our findings suggest that it’s important to have a conversation with stroke patients about physical activity resources available in their area so they are able to continue their recovery after hospital discharge. If their neighborhood does not offer fitness resources, neurologists should consider discharging the patient to a rehabilitation facility where they can participate in physical activities.”


    Jeffrey Wing, Ph.D., M.P.H., lead study author, assistant professor of epidemiology at The Ohio State University in Columbus, Ohio

    In this study, researchers examined the potential link between available fitness/exercise centers, pools and gyms and physical activity among 333 people living in New York City who had a mild stroke.The data was geocoded, assigned to the U.S. census tracts, and merged with data from the National Neighborhood Data Archive (collects information about the number of physical activity resources at the census tract level). Geocoding is the process of transforming a description of a location -; such as an address or a name of a place -; to a location on the earth’s surface. Researchers then examined the association between the number of fitness and recreational centers, such as pools, gyms and skating rinks per square mile, and the self-reported change in physical activity levels -; more active, about the same or less active -; one year after stroke.

    The analysis found:

    • About 17% of participants reported being more physically active one year after stroke, and 48% reported having about the same level of physical activity as before the stroke.

    • The odds of being more active were 57% higher among participants who lived in areas with more recreational and fitness resources (about 58 fitness resources) compared to people living in neighborhoods with fewer or no fitness resources, after controlling for age, gender, race, ethnicity, education, health insurance and body mass index.

    • Similarly, the odds of reporting the same level of physical activity one year after stroke were 47% higher in participants who lived in areas with more recreational centers and fitness resources compared to those who lived in areas with fewer or no resources available.

    Previous research has shown that even moderate physical activity is beneficial for stroke recovery and can include walking, Wing said. “However, it’s important to recognize the availability or limited availability of exercise resources in a person’s immediate neighborhood and to be able to feel safe while participating in exercise activities.”

    Previous research has found that the characteristics of the built environment of a neighborhood, such as access to healthy food or recreational spaces promoting physical activity, were also linked to lower incidence of stroke, Wing noted.

    “The takeaway from this analysis is that it’s not that people should move to a location where there are more resources to engage in physical activity, but to urge people to find ways to be active in their own neighborhood,” said study co-author Julie Strominger, a Ph.D. student of epidemiology at The Ohio State University. “It’s the action that will lead to better outcomes, so just the action of being physically active is what really matters.”

    “This study is consistent with prior research on the importance of physical activity for optimal health. The new aspect is the focus on stroke survivors,” said American Stroke Association volunteer expert and EPI and Stroke Council member Daniel T. Lackland, Dr.P.H., FAHA, professor of epidemiology and director of the Division of Translational Neurosciences and Population Studies in the department of neurology at the Medical University of South Carolina in Charleston. “It’s important for health care professionals to discuss maintaining physical activity with stroke survivors: find out if they know of a safe place to exercise, and if they do not, have that information readily available.” Lackland was not involved in the study.

    Study details and background:

    • The analysis included 333 adults hospitalized for mild stroke and enrolled in the Discharge Educational Strategies for Reduction of Vascular Events (DESERVE) study.

    • The DESERVE study was a randomized clinical trial of 546 stroke survivors and conducted in New York City from 2012-2016.

    • Participants were 52% women, with an average age of 65 years; they self-identified as 35% Hispanic adults, 31% Black adults, 28% white adults and 6% as “other” race.

    The main limitations of the study, according to the authors, are that the findings may not be generalizable to non-urban neighborhoods in the U.S. In addition, the data was extracted from a clinical trial that included only stroke survivors who had a mild stroke, therefore, this association may not hold true for survivors of severe stroke. Also, while people in certain neighborhoods reported more physical activity, that does not necessarily mean that they used the fitness and recreational resources in their neighborhood.

    Source:

    American Heart Association

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