Clinical Studies for Neurology

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Title: Using High Definition transcranial Direct Current Stimulation to Treat Verbal Retrieval Deficits Secondary to Chronic Traumatic Brain Injury (STIM-CTBI)
Brief Title: HDtDCS for verbal deficits in chronic TBI
For info regarding 2025P000171 please contact Hsueh-Sheng Chiang at 617-667-8289 or hchiang3@bidmc.harvard.edu
 
Title: CALM: Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Brief Title: CALM
For info regarding 2024P000805 please contact MIa Hemme at 617-667-3069 or mhemme@bidmc.harvard.edu
 
Title: Neuromodulation and cognitive behavioral therapy for insomnia in MCI
Brief Title: Insomnia in MCI
For info regarding 2024P000708 please contact Alex Diamond at 617-667-0386 or adiamon2@bidmc.harvard.edu
 
Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in CompanionDiagnostic-Positive Participants with Early Parkinson’s Disease
Brief Title: Early Parkinson’s Disease Therapy with NEU-411
For info regarding 2024P000654 please contact Hannah Babcock at 617-667-9890 or hbabcock@bidmc.harvard.edu
 
Title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson’s Disease (LRRK2-PD)
Brief Title: Safety and Pharmacodynamic Effects of BIIB122 in Participant
For info regarding 2024P000639 please contact Hannah Babcock at 617-667-9890 or hbabcock@bidmc.harvard.edu
 
Title: A Phase 2, randomized, blinded, placebo-controlled study to evaluate safety, tolerability, pharmacometrics and efficacy of DNTH103 in adults with generalized Myasthenia Gravis ( MAGIC)
Brief Title: DNTH103 in adults with generalized Myasthenia Gravis ( MAGI
For info regarding 2024P000498 please contact Amy Lewandowski at 617-667-2545 or alewand2@bidmc.harvard.edu
 
Title: FREXALT: Master Protocol of Two Independent, Randomized, Double-Blind, Phase 3 Studies Comparing Efficacy And Safety Of Frexalimab (Sar441344) To Teriflunomide In Adult Participants With Relapsing Forms Of Multiple Sclerosis
Brief Title: FREXALT (EFC17919)
For info regarding 2024P000493 please contact Jacob Sloane, MD at 617-667-3726 or vsingh4@bidmc.harvard.edu
 
Title: FREVIVA: A randomized, double-blind, Phase 3 study comparing efficacy and safety of frexalimab (SAR441344) to placebo in adult participants with nonrelapsing secondary progressive multiple sclerosis
Brief Title: FREVIVA (EFC17504)
For info regarding 2024P000492 please contact Jacob Sloane, MD at 617-667-3726 or vsingh4@bidmc.harvard.edu
 
Title: Therapeutic Amyloid Reduction and Cortical Excitability in Alzheimers disease
Brief Title: TRACE-AD
Brief Summary: The purpose of this study is to understand how amyloid removal is beneficial to the brain in Alzheimers Disease. We hope this will help us improve future treatment options. We will enroll 40 Alzheimers disease participants who are planning to start lecanemab (an anti-amyloid agent) through BIDMCs clinical treatment program. TMS and EEG measures of cortical excitability will be assessed at Baseline and periodically over 18 months of treatment. This study will allow us to determine the extent to which the beneficial effects of amyloid removal on cognitive decline may be mediated through improvements in cortical excitablity. If you qualify for and take part in the study, you would undergo all study related visits and testing at no charge. The study requires approximately 12 in-person visits. You will be compensated for your time and transportation will be provided for any in-person visits.
For info regarding 2024P000337 please contact Stephanie Buss at 617-975-8542 or sbuss@bidmc.harvard.edu
 
Title: Enhancing Sleep in Older Adults Using Auditory and Transcranial Stimulation: A Machine Learning Approach
Brief Title: Enhancing sleep in older adults with noninvasive stimulation
Brief Summary: The main purpose of this study is to explore the effects of noninvasive brain stimulation (neuromodulation) on slow wave sleep and cognition. The types of brain stimulation that will be used are auditory stimulation (AS) and transcranial alternating current stimulation (tACS). The AS device, SleepLoop, and tACS device, Starstim, involved in this study are investigational. This study will investigate whether AS and tACS can affect slow waves (a type of brain activity that occurs during deep sleep and is closely linked to memory and learning) during sleep to improve short-term cognition.
For info regarding 2024P000148 please contact Stephanie Buss, MD at sbuss@bidmc.harvard.edu
 
Title: A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study toDetermine the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for StrokePrevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack-LIBREXIA-STROKE (Sponsor protocol 70033093STR3001)
Brief Title: LIBREXIA Stroke
For info regarding 2024P000117 please contact Jennifer Dearborn-Tomazos at 617-667-1803 or jtomazos@bidmc.harvard.edu
 
Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Global Study to Evaluate the Efficacy and Safety of Intravenous AOC 1001 for the Treatment of Myotonic Dystrophy Type 1
Brief Title: HARBOR
For info regarding 2024P000071 please contact Teresa Capella at 617-667-3098 or tcapella@bidmc.harvard.edu
 
Title: Expectations and Experiences of Narcolepsy Symptoms in Pregnancy
Brief Title: Narcolepsy Symptoms in Pregnancy
Brief Summary: This study seeks to fill the critical knowledge gap on the evidence-based management of narcolepsy type 1 (narcolepsy with cataplexy) during pregnancy. By gathering data on the severity and impact of narcolepsy symptoms before, during, and after pregnancy, this mixed-methods study aims to better define symptom trajectory, treatment approaches, and current gaps in care for pregnant people with narcolepsy. This study will include an on-line questionnaire plus an optional interview.
For info regarding 2023P001041 please contact Margaret Blattner, MD PhD at 617-667-3237 or mblattne@bidmc.harvard.edu
 
Title: Parkinsons Disease Repository
Brief Title: Parkinsons Disease Repository
Brief Summary: The purpose of this protocol is to establish a repository of patients with Parkinsons disease (PD) or parkinsonism and collect a range of variables to inform future research project development, future research questions and overall program development. This repository will also aid in the facilitation and coordination of patient engagement in research protocols, collect screening information, and track patients through ongoing and completed studies and study-related procedures.
For info regarding 2023P000893 please contact Aine Russell at 617-667-2351 or arussel2@bidmc.harvard.edu
 
Title: Identifying dynamic biomarkers associated with rTMS response in depression: a pilot study
Brief Title: Dynamic biomarkers of rTMS response in depression
Brief Summary: Repetitive transcranial magnetic stimulation (rTMS) is a highly effective for medication-resistant depression. For treatment to be effective, individuals invest extensive time and money undergoing rTMS daily for six weeks. However, rTMS is only 30-50% effective, and individuals may not know if they have responded until the middle or end of treatment course. Here, we aim to collect EEG and MRI data throughout rTMS treatment in patients undergoing rTMS at the Berenson-Allen Center - by doing so, we hope to identify signals that predict response early on in treatment course.
For info regarding 2023P000469 please contact Roscoe Brady Jr. MD PhD at 617-754-1261 or robrady@bidmc.harvard.edu
 
Title: Tablet application for the screening and monitoring of movement disorders
Brief Title: Drawing Analysis for Screening of Parkinsons Disease
Brief Summary: We are trying to develop a way to measure movement disorders in people (e.g. Parkinsons Disease). We are testing people on a variety of drawing tasks using an iPad and a stylus. We plan to analyze how people perform on the tasks. We will use this information to create more accurate, faster, and more convenient tasks and determine whether these drawing tasks will provide us with information that is useful in understanding which movement disorder a patient has or whether they do not have a movement disorder.
For info regarding 2023P000280 please contact Jay Iyer at jiyer@bidmc.harvard.edu
 
Title: Feasibility of the comfort measures only time out (CMOT) to reduce distress during Palliative Withdrawal of Mechanical Ventilation
Brief Title: Feasibility of comfort measures only time out (CMOT)
For info regarding 2023P000160 please contact Corey Fehnel at 617-667-7000 or cfehnel@bidmc.harvard.edu
 
Title: Department of Neurology Biorepository     
Brief Title: Department of Neurology Biorepository
Brief Summary: The purpose of this study is to collect and store samples (for example, blood and saliva) in patients with different neurologic disorders (for example, Parkinsons Disease, Epilepsy, Stroke) to be used for future research to learn more about diagnosing, preventing and treating neurologic disorders.
For info regarding 2023P000108 please contact Neurology Biorepository Research Team at 617-667-0605 or NeuroRepository@bidmc.harvard.edu
 
Title: A novel protocol for diagnosing idiopathic hypersomnia
Brief Title: Home sleep testing for diagnosing Idiopathic Hypersomnia
For info regarding 2023P000058 please contact Liz Roy at 617-975-7636 or eroy2@bidmc.harvard.edu
 
Title: Characterizing non-restorative sleep in post-viral disease to advance intervention innovations
Brief Title: Nonrestorative sleep in post-viral disease
Brief Summary: This study is being done to understand why people with (ME/CFS) and Long COVID may experience nonrestorative sleep. Non-restorative sleep means that you do not feel refreshed or well rested after sleeping. We hope to learn more about things that might affect your sleep. For example, how your bodys systems, such as your immune system (the system that helps you fight infections) and hormones (chemicals that signal different functions in your body) are related to non-restorative sleep. We hope that learning more about non-restorative sleep can help with future treatment.
For info regarding 2022P001036 please contact Janet Mullington, PhD at 617-667-5243 or postviralsleep@bidmc.harvard.edu
 
Title: Prospective validation of electronic seizure diary forecasting
Brief Title: Prospective validation of electronic seizure diary forecasti
Brief Summary: This study hopes to be able to find a method to forecast, or predict, when seizures will happen in those with temporal lobe epilepsy. This would allow someone to take the necessary precautions in order to alleviate, or even prevent, a seizure event. This is a virtual study, and participants will be using a website and an app to track their seizures and medications. Participation is approximately 10 months.
For info regarding 2022P000548 please contact Daniel Goldenholz at 617-632-8930 or EpilepsyPlusDataScience@bidmc.harvard.edu
 
Title: Electrophysiological and ultrasound quantitative biomarkers for myofascial pain
Brief Title: Quantitative biomarkers for myofascial pain
For info regarding 2022P000543 please contact Seward Rutkove at 617-667-8130 or srutkove@bidmc.harvard.edu
 
Title: Abbott DBS Post market Study of Outcomes for Indications over Time
Brief Title: ABT-CIP-10300
For info regarding 2022P000324 please contact Aine Russell at 617-667-1337 or arussel@bidmc.harvard.edu
 
Title: Audio Markers of Speech and Cognition in Neurodegenerative Disease (Audio-ND)
Brief Title: Audio-HD
Brief Summary: The purpose of this research is to establish biomarkers (a medical sign that can be measured reliably) for both speech and cognitive impairment in Huntingtons disease using a speech analyzing application. Participants must either have a confirmed genetic diagnosis of Huntingtons disease or be a heathy volunteer. Participants will undergo demographics and medical history review, cognitive tests, questionnaires, and a 10-minute speech assessment.
For info regarding 2022P000181 please contact Luis Sierra at 617-667-2351 or hdresearch@bidmc.harvard.edu
 
Title: Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Brief Title: CAPTIVA
For info regarding 2022C000315 please contact Sarah Marchina at smarchin@bidmc.harvard.edu
 
Title: Visual restoration of losses caused by cortical damage: a new protocol to promote fast recovery
Brief Title: Reduction of Visual Field Deficits
For info regarding 2021P000804 please contact Lorella Battelli at 617-667-0203 or lbattell@bidmc.harvard.edu
 
Title: Parkinson’s Foundation PD GENEration Genetic Registry
Brief Title: Parkinson’s Foundation PD GENEration Genetic Registry
For info regarding 2021P000373 please contact Aine Russell at 617-667-9885 or arussel2@bidmc.harvard.edu
 
Title: Brain Plasticity in Type-2 Diabetes
Brief Title: Brain Plasticity in Type-2 Diabetes
Brief Summary: The overall goal of this research is to learn more about changes in the structure and physiology (function) of the brain that occur in people with diabetes as they get older and how these changes relate to cognition (thinking) and other markers of brain health. By comparing the results from the diabetes groups with people who do not have diabetes, we hope to increase our understanding of why some people with diabetes develop problems with their cognition as they get older and have a higher risk of developing Alzheimers disease. You are invited to take part in this research study if you have type-2 diabetes or are in good overall health and you have not been diagnosed with mild cognitive impairment or dementia. The study includes about 6 in-person research visits, to be completed in about 8-10 weeks.
For info regarding 2020P001152 please contact Andrew Northrop at (617)667-0271 or anorthro@bidmc.harvard.edu
 
Title: HEALEY ALS Platform Trial
Brief Title: HEALEY ALS Platform Trial
For info regarding 2020C000221 please contact Seward Rutkove at 617-667-8130 or srutkove@bidmc.harvard.edu
 
Title: Neural networks in presymptomatic Huntingtons Disease
Brief Title: Neural networks in presymptomatic Huntingtons Disease
Brief Summary: The primary aim of this study is to investigate the changes in the neural networks of attention in the early “presymptomatic” phase of Huntington’s disease. The second aim is to correlate these imaging changes with performance on a cognitive/attentional task.
For info regarding 2019P000943 please contact Luis Sierra at 617-667-2351 or hdresearch@bidmc.harvard.edu
 
Title: Prevalence and impact of obstructive sleep apnea in multiple sclerosis
Brief Title: Prevalence and impact of obstructive sleep apnea in multiple
For info regarding 2019P000494 please contact Vikrum Singh at 617-667-3726 or vsingh4@bidmc.harvard.edu
 
Title: Treating Hyperexcitability in Alzheimers Disease with Levetiracetam to Improve Brain Function and Cognition
Brief Title: Treating Hyperexcitability in AD with LEV
For info regarding 2019P000091 please contact Carol Abedelnour at 617-667-0386 or cabedeln@bidmc.harvard.edu
 
Title: Anticoagulation in Intracerebral Hemorrhage (ICH) Survivors for Stroke Prevention and Recovery
Brief Title: ASPIRE
For info regarding 2019C000787 please contact Magdy Selim at 617-632-8913 or mselim@bidmc.harvard.edu
 
Title: Sleep for Stroke Management And Recovery Trial
Brief Title: SleepSMART
For info regarding 2019C000228 please contact Sarah Marchina at smarchin@bidmc.harvard.edu
 
Title: The Functional Neuroanatomy of the Human Physiological Stress Response
Brief Title: Functional Neuroanatomy of Physiological Stress
For info regarding 2019C000177 please contact Roy Freeman at 617-632-8454 or rfreeman@bidmc.harvard.edu
 
Title: A Prospective Registry Study in a Global Huntingtons Disease Cohort
Brief Title: A Prospective Registry Study in a Global Huntingtons Diseas
For info regarding 2018P000332 please contact Samuel Frank at 617-667-4889 or sfrank2@bidmc.harvard.edu
 
Title: StATins Use in intRacereberal hemorrhage patieNts
Brief Title: (Statins in ICH (SATURN Trial)
For info regarding 2018C000515 please contact Magdy Selim at 617-632-8913 or mselim@bidmc.harvard.edu