Clinical Studies for Neurology

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Title: Neuromodulation and cognitive behavioral therapy for insomnia in MCI
Brief Title: Insomnia in MCI
Brief Summary: The goal of this study is to test a new way to improve sleep quality in persons living with mild cognitive impairment. The treatment combines a safe and gentle way to stimulate the brain, called transcranial magnetic stimulation, with a psychological treatment, called cognitive behavioral therapy for insomnia.
For info regarding 2024P000708 please contact Alex Diamond at 617-667-0386 or adiamon2@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
Brief Summary: The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).
For info regarding 2024P000498 please contact Amy Lewandowski at 617-667-2545 or alewand2@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
Brief Summary: The purpose of this study is to evaluate whether milvexian compared to placebo reduce the risk of recurrent ischemic stroke.
For info regarding 2024P000117 please contact Jennifer Dearborn-Tomazos at 617-667-1803 or jtomazos@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)
Brief Summary: Nearly 25% of Americans die in intensive care units (ICUs). Most deaths in ICUs are expected and involve the removal of ventilator support, or palliative withdrawal of mechanical ventilation (WMV). Prior work by the Principal Investigator (PI) found that patient suffering can be common; with 30-59% of patients going through this process experiencing distress. Thus, experts and national organizations have called for evidence to inform guidelines for WMV. This research study will 1) develop and refine a Comfort Measures Only Time out (CMOT) intervention consisting of a structured time out with check-list protocol for the ICU team (nurse, physician, respiratory therapist) to improve the process of WMV. and 2) Pilot test the CMOT intervention in 4 ICUs (2 medical/2 surgical) among 40 WMV patients.
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
Brief Summary: This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome. Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study. Electrical impedance myography (EIM), myofiber threshold tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE) measurements will be obtained from the trapezius muscle (the muscle that extends over the back of the neck and shoulders). These measurements will be repeated within 2-5 days to assess repeatability of these methods.
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
Brief Summary: The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.
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
Brief Summary: The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.
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
Brief Summary: This is a randomized, pilot interventional study in participants with visual field deficit (VFD) caused by cortical lesion. Damage to the primary visual cortex (V1) causes a contra-lesional, homonymous loss of conscious vision termed hemianopsia, the loss of one half of the visual field. The goal of this project is to elaborate and refine a rehabilitation protocol for VFD participants. It is hypothesized that visual restoration training using moving stimuli coupled with noninvasive current stimulation on the visual cortex will promote and speed up recovery of visual abilities within the blind field in VFD participants. Moreover, it is expected that visual recovery positively correlates with reduction of the blind field, as measured with traditional visual perimetry: the Humphrey visual field test or an eye-tracker based visual perimetry implemented in a virtual reality (VR) headset. Finally, although results will vary among participants depending on the extent and severity of the cortical lesion, it is expected that a bigger increase in neural response to moving stimuli in the blind visual field in cortical motion area, for those participants who will show the largest behavioral improvement after training. The overarching goals for the study are as follows: Group 1a will test the basic effects of transcranial random noise stimulation (tRNS) coupled with visual training in stroke cohorts, including (i) both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants, and (ii) longitudinal testing up to 6 months post-treatment. Group 1b will test the effects of transcranial tRNS coupled with visual training on a Virtual Reality (VR) device in stroke cohorts, including both chronic/subacute ischemic and chronic hemorrhagic VFD stroke participants. Group 2 will examine the effects of tRNS alone, without visual training, also including chronic and subacute VFD stroke participants and longitudinal testing.
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
Brief Summary: To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).
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: Brain Plasticity in Cognitive Aging
Brief Title: Plasticity in cognitive aging
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 as people age and how these changes relate to cognition (thinking) and other markers of brain health. You are invited to take part in this research study if you are in good overall health and you have not been diagnosed with mild cognitive impairment or dementia. The study includes 4 in-person research visits, to be completed in about 6 weeks.
For info regarding 2020P000889 please contact Christie Morse at (617)667-8412 or cmorse2@bidmc.harvard.edu
 
Title: HEALEY ALS Platform Trial
Brief Title: HEALEY ALS Platform Trial
Brief Summary: The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
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
Brief Summary: This study will evaluate the influence of sleep apnea on clinical and radiological features of MS. Sleep apnea is associated with hypoxemia during sleep, which is likely detrimental to MS. Clinical data (MRI, lab results, medical history, labs, and sleep studies) of MS patients will be collected and analyzed. This will be done to study correlations between MRI, clinical data, lab studies and sleep studies. There is specific interest in the type of sleep apnea associated with MS, and whether MRI or clinical metrics of MS severity correlate with presence or absence of sleep apnea.
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
Brief Summary: The aim of this study is to explore the relationship between cortical hyperexcitability, abnormalities of brain network function, and cognitive dysfunction in human patients with AD and whether administration of the antiepileptic medication levetiracetam (LEV) normalizes these measures and improves cognition.
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
Brief Summary: Primary Aim: To determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF). Secondary Aim: To determine if apixaban, compared with aspirin, results in better functional outcomes as measured by the modified Rankin Scale.
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
Brief Summary: The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.
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
Brief Summary: The purpose of this study is to examine the effect of a moderately low blood sugar stress on the nervous system. The investigators hope that information obtained from completing this study will help to reveal information about how a non-psychological stress impacts the parts of the brain that react to stress and the autonomic nervous system. The autonomic nervous system is the part of the nervous system that provides the body with involuntary or automatic control of heart rate, blood pressure, and breathing.
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
Brief Summary: Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 30,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.
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)
Brief Summary: The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype. An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on baseline MRI influences the risk of ICH recurrence on/off statin therapy.
For info regarding 2018C000515 please contact Magdy Selim at 617-632-8913 or mselim@bidmc.harvard.edu