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Title: PPD CorEvitas Myasthenia Gravis (MG) Drug Safety and Effectiveness Registry
Brief Title: MG Registry
Brief Summary: The design is a prospective, observational (non-interventional) registry for subjects with myasthenia gravis under the care of a neurology provider. Longitudinal data are collected from both subjects and their treating neurology provider during routine clinical encounters using a structured and standardized data collection method. Approximately 1,500 myasthenia gravis subjects with no defined upper limit and 50 clinical neurology sites will be recruited.
For info regarding 2026P000291
please contact Pushpa Narayanaswami at 617-667-8130 or
pnarayan@bidmc.harvard.edu
Title: ACCOMPLISH-PD: Phase 2, double-blind, placebo-controlled study to evaluate the effectiveness of two doses of AP-472 as adjunctive therapy to levodopa in Parkinson’s disease (PD) participants with motor fluctuations
Brief Title: ACCOMPLISH-PD
Brief Summary: This is a Phase 2 study in people with Parkinsons disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo.
For info regarding 2026P000035
please contact PD Research at
pdresearch@bidmc.harvard.edu
Title: Invest-HD: A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of Votoplam in participants with Huntington’s Disease
Brief Title: Invest HD
Brief Summary: The purpose is to assess safety and tolerability of votoplam and to determine whether votoplam slows disease progression in patients with early symptomatic Huntingtons disease (HD) compared to the control arm. HTT227 - current compound code (former code is PTC518 from PTC Therapeutics), HTT227 is Novartis code under Novartis sponsorship. This study will have a variable double-blind treatment duration of up to 36 months. As part of the study design, not every participant will complete 36 months of treatment. The study consists of 3 periods:
Screening Period: A period of up to 42-days to assess participants eligibility
Double-blind Treatment Period: This period will have variable individual treatment duration, up to 36 months. The double-blind treatment period concludes when ≥50% patients complete Month 36. The maximum treatment duration for an individual participant is 36 months.
Safety Follow-up Period: A period consisting of one safety follow-up visit, conducted on site or by phone call, for all participants not continuing treatment in the separate open-label extension study or discontinuing early. The visit/phone call will take place 30 days after End of Study (EOS)
For info regarding 2025P001003
please contact Samuel Frank at 617-667-4889 or
sfrank2@bidmc.harvard.edu
Title: Stride Dystonia: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Vim0423 In Individuals With Isolated Dystonia
Brief Title: Stride Dystonia
Brief Summary: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study designed to assess the efficacy, safety, and tolerability of VIM0423 (administered orally) in adults with isolated dystonia that affects two or more body regions. Participants will be randomized 1:1 to receive either oral VIM0423 or placebo. Two distinct subtypes of participants (segmental/multifocal dystonia or generalized dystonia) will be enrolled.
For info regarding 2025P000991
please contact Hannah Babcock at 617-667-9890 or
hbabcock@bidmc.harvard.edu
Title: The impact of dry needling on electrophysiological and ultrasound-based biomarkers for myofascial pain
Brief Title: The impact of dry needling on biomarkers for myofascial pain
Brief Summary: The goal of this interventional study is to determine how well dry-needling can treat
pain in people with Myofascial Pain Syndrome. The main questions it aims to answer are:
- Does dry needling improve pain for people with a trigger point (a tender, tight spot
in the muscle)?
- How well can Electrical Impedence Myography (EIM), Myofiber Threshold Tracking (TT),
and Ultrasound (US) detect changes in the muscle related to dry needling treatment?
Researchers will compare dry needling to a placebo (a treatment that does not enter the
trigger point) to see if dry needling works to treat Myofascial Pain Syndrome with
trigger points in the trapezius muscle (the muscle that extends over the back of the neck
and shoulders), as measured by these three outcome measures (EIM, US, TT).
Participants will:
- Visit the clinic twice: once to receive dry needling treatment, and once for a
follow-up
- Have muscle measurements taken before treatment and at follow-up
- Have a daily survey to record the intensity of their pain
For info regarding 2025P000944
please contact Seward Rutkove at 617-667-8130 or
srutkove@bidmc.harvard.edu
Title: A prospective long term follow-up study to evaluate the use of the Minder device to aid in treatment after actionable event identification in patients diagnosed with epilepsy
Brief Title: Long-term follow-up of Minder device in epilepsy
Brief Summary: The purpose of this research is to address the challenges of correctly monitoring,
managing, and diagnosing epilepsy in participants whose seizures are not well captured by
standard electroencephalography (EEG) tests and who cannot use or are not able to use
more standard monitoring techniques. This research is being done to understand how the
Minder System helps physicians make decisions about participant's epilepsy treatment
after an actionable event. The Minder System was granted De Novo classification by the
U.S. Food and Drug Administration (FDA) and is not investigational.
Participants that have completed the DETECT study and received the Minder System
previously will consent to join this long-term follow-up observational study. The study
will collect information about general wellbeing, use of healthcare services, and
experience using the Minder data over time to support long-term epilepsy care.
All participants will continue to be followed by their treating physician and undergo
assessments and visits every six (6) months until two (2) years after receiving the
Minder device.
For info regarding 2025P000783
please contact Niravkumar Barot at
nbarot@bidmc.harvard.edu
Title: An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia
Brief Title: A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy a
Brief Summary: This is a Phase 2/3, randomized, long-term extension, dose-range-finding study to evaluate the longterm durability, safety, and tolerability of ALKS 2680 in subjects with IH, NT1, and NT2.
For info regarding 2025P000758
please contact Monica Makhija at 617-667-3237 or
mmakhija@bidmc.harvard.edu
Title: A prospective, randomized controlled, blinded, multi-center study to evaluate the use of the Minder device to aid in developing a treatment plan after inconclusive prolonged EEG in patients with epilepsy
Brief Title: Diagnosing epilepsy using Minder
Brief Summary: The purpose of this research is to address the challenges of diagnosing and long-term
management of epilepsy in participants whose seizures are not well captured by standard
electroencephalography (EEG) tests and who cannot use or are not able to use more
standard monitoring techniques. This research will compare the Minder System to standard
of care in providing reliable seizure data. The Minder System was granted De Novo
classification by the U.S. Food and Drug Administration (FDA) and is not investigational.
Participants will consent to join the study and be implanted with the Minder device; or
consent to join the study and continue with their Standard of Care (SOC) as a control
group. Participants chose to be implanted with the Minder device will have the device
implanted under their scalp. After implantation, participants will be randomly assigned
to a group where their treating physician will have access to the EEG data collected by
the Minder System or a group where their treating physician does not have access to the
EEG data collected by the Minder System. Participants receiving the Minder System will
not know which group they are in (blinded) until the study ends.
All participants will continue to be followed by their treating physician and undergo
assessments and visits until enough information is available to determine a treatment
plan or the 6-month follow-up visit.
For info regarding 2025P000700
please contact Niravkumar Barot at
nbarot@bidmc.harvard.edu
Title: A Phase 2, Open-label, Proof-of-Concept Study to Investigate the Efficacy, Safety, and Tolerability of TAK-411 in Adult Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (The CASCA Study)
Brief Title: The CASCA Study
Brief Summary: CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system
attacks itself. In CIDP, the immune system attacks the protective covering around the
nerves called myelin. Over time, these nerves lose their ability to send signals to the
muscles in the body. This leads to muscle weakness and loss of sensation in arms and legs
among other symptoms. Participants with CIDP can be treated with a protein called
immunoglobulin (or IG).
TAK-411 is a special type of immune globulin G (hsIgG) that has been chemically changed.
It is made from IG that comes from human plasma. This study will test if TAK-411 can
decrease inflammation and improve symptoms of CIDP.
The main aim of this study is to check how TAK-411 affects the physical functioning of
adults with CIDP when compared with results of the placebo group of a historical trial.
Participants may be treated with TAK-411 for up to 1 year (51 weeks) and will be followed
up for 3 weeks after last dose.
During the study, participants may visit their study clinic up to approximately 21 times.
For info regarding 2025P000641
please contact Fernanda Wajnsztajn Yungher at
fwajnszt@bidmc.harvard.edu
Title: Characterizing body temperature across the menstrual cycle in reproductive-age day and night shift working nurses
Brief Title: Temperature in day and night shift working women
Brief Summary: We invite female nurses in the Longwood Medical Area between the ages of 18-35 to consider participating in this study. Specifically, we are seeking nurses who work only day or only night shifts, who are not taking hormonal birth control, and who are not pregnant or actively trying to become pregnant. The study will be conducted in the BIDMC Clinical Research Center and will involve brief, in-person study visits, body temperature collection across the menstrual cycle using different types of temperature collection devices, questionnaires, and urine sample collection.
This study is being done to understand whether female nurses between the ages of 18 and 35, who work night-shifts, show temperature irregularities across their menstrual cycle, compared to those nurses who work more standard, day shifts. The study will also help us determine whether peripheral temperature recording devices accurately reflect the internal core body temperature (and potential temperature irregularities that may occur when working night shifts). Learning more about temperature dynamics across the menstrual cycle of both day and night-shift working females could help with future fertility treatments, given that many night-shift working women experience infertility.
For info regarding 2025P000624
please contact Sydney Aten, PhD at
saten@bidmc.harvard.edu
Title: An open label pilot study of infrared photobiomodulation in humans with epilepsy
Brief Title: photobiomodulation in epilepsy
Brief Summary: Drug-resistant epilepsy represents roughly 40% of people with epilepsy. It is very
challenging to stop seizures in this condition, and the treatment options are limited.
This study aims to investigate a new treatment that involves using infra-red light. In
animals, this treatment has shown promise as a possible way to reduce seizures, but it
has not been tested in humans for this. The investigators are interested to know if it
can reduce seizures, and how comfortable it is to be treated with this therapy.
For info regarding 2025P000606
please contact Daniel Goldenholz at 617-632-8934 or
dgoldenh@bidmc.harvard.edu
Title: A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and
Efficacy of ALKS 2680 in Subjects with Idiopathic Hypersomnia
Brief Title: A Study to Evaluate the Safety and Effectiveness of ALKS 268
Brief Summary: The purpose of this study is to assess the safety and efficacy of ALKS 2680 (alixorexton) compared to the placebo in participants with Idiopathic Hypersomnia (IH). ALKS 2680 is a new, investigational drug that is classified as an orexin 2 receptor agonist. Orexin is a substance that helps control sleep/wake cycles. ALKS 2680 works similarly to orexin and may improve excessive sleepiness in people with Idiopathic Hypersomnia (IH). This study consists of 2 groups, referred to as parts: Part A and Part B. Part A participants will be randomly assigned to one of four study drug doses (10mg, 14 mg, 18mg of ALKS 2680, or placebo). Part B participants will be randomly assigned to one of two study drug doses (24 mg tablets given as split dose, or placebo).
For info regarding 2025P000531
please contact Monica Makhija at 617-667-3237 or
mmakhija@bidmc.harvard.edu
Title: PRISMS: An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons with REM Sleep Behavior Disorder (RBD)
Brief Title: PRISMS
Brief Summary: This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.
For info regarding 2025P000520
please contact Lan Luo at 617-667-1337 or
lluo2@bidmc.harvard.edu
Title: Development of the Tremor Exam for the Office (TEO)
Brief Title: 3-Minute Tremor Exam for the Office (TEO)
Brief Summary: The purpose of this study is to develop a potential new clinical rating scale for essential tremor. Participation in this observational study requires one in-person study visit at BIDMC in which you will answer survey questions and have your tremor symptoms recorded on video.
For info regarding 2025P000479
please contact Jackie Forbes at 617-667-9885 or
jforbes1@bidmc.harvard.edu
Title: A Global Phase 3 Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Intravenous AOC 1001 for the Treatment of Myotonic Dystrophy Type 1
Brief Title: Harbor OLE
Brief Summary: A Global Phase 3 Open-Label Extension Study to Assess the Long-Term Safety, Tolerability,
and Efficacy of Intravenous Delpacibart Etedesiran (abbreviated del-desiran, formerly AOC
1001) for the Treatment of Myotonic Dystrophy Type 1
For info regarding 2025P000422
please contact Seward Rutkove at 617-667-8130 or
srutkove@bidmc.harvard.edu
Title: Brain Age Sleep Indices of Longitudinal Cognition
Brief Title: BASILsC
Brief Summary: The main goal of this study is to explore how sleep affects memory, attention, and overall brain function in adults by using two wearable and non-invasive devices called Muse S, and Oura Ring. The Muse S is a headband that tracks your brain activity; and the Oura Ring is a ring that tracks your breathing, heart rate, sleep quality, recovery, and overall wellness. Well collect data on your sleep and heart health for up to 20 nights within 3
months and will also ask you to complete mental tasks the morning after. By doing this, we hope to find patterns that could help us understand what healthy brain aging looks like and to spot early signs of memory or thinking problems. This research could lead to ways to support brain health and prevent issues as we get older.
For info regarding 2025P000336
please contact Kaileigh Gallagher at
kgallag2@bidmc.harvard.edu
Title: exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain
Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants
With Parkinson’s Disease
Brief Title: exPDite-2
Brief Summary: Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled,
double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102
adults with Parkinson's Disease (PD).
For info regarding 2025P000294
please contact Ludy Shih at 617-667-2822 or
lshih@bidmc.harvard.edu
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
Brief Summary: The purpose of this study is to learn more about how brain stimulation affects word
finding problems in people who have a traumatic brain injury (TBI). The type of brain
stimulation used is called transcranial direct current stimulation (tDCS). tDCS delivers
low levels of electric current to the brain and high definition tDCS (HD-tDCS) delivers
the current with multiple electrodes on the scalp. This current is delivered with HD-tDCS
to parts of the brain that may help with remembering things. The investigators hope that
this can help to improve word finding and memory problems in people with TBI.
For info regarding 2025P000171
please contact Hsueh-Sheng Chiang at 617-667-8289 or
hchiang3@bidmc.harvard.edu
Title: A Phase 1/2, Randomized, Sequential, Dose Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of a One-Time, Bilateral, Intraparenchymal Infusion of SPK10001 Into the Caudate and Putamen in Participants With Huntington’s Disease
Brief Title: AAVAIL-HD
Brief Summary: The main goal of this study is to evaluate the safety, tolerability, and preliminary
efficacy of SPK-10001 in participants with Huntington's Disease.
For info regarding 2024P000988
please contact Clementina Ullman at 617-667-2355 or
cullman@bidmc.harvard.edu
Title: A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T-cells (CABA-201) in Participants with Generalized Myasthenia Gravis (CAB-201-004)
Brief Title: RESET-MG
Brief Summary: RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in
Participants with Generalized Myasthenia Gravis
For info regarding 2024P000986
please contact Amy Lewandowski at 617-667-2545 or
alewand2@bidmc.harvard.edu
Title: CALM: Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study
Brief Title: CALM
Brief Summary: Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for
treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the
MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM
will gather additional preliminary evidence of clinical safety and potential
effectiveness in this patient population with a longer follow-up period and additional
secondary endpoints in a single-arm study prior to commencing a larger sham-controlled
pivotal trial.
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
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: NEULARK: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson’s Disease
Brief Title: Early Parkinson’s Disease Therapy with NEU-411
Brief Summary: The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of
NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have
predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for
short) pathway based on their genetic profile. A DNA test will be used to identify the
"LRRK2-driven" population with predicted elevation in the LRRK2 pathway.
For info regarding 2024P000654
please contact Hannah Babcock at 617-667-9890 or
hbabcock@bidmc.harvard.edu
Title: ENABLE: Real world experience with BRIUMVI (ublituximAB-xiiy) treated patients: a longitudinal registry study
Brief Title: ENABLE
Brief Summary: The purpose of this study is to evaluate safety, effiectiveness, and to gain insight into
the treatment experience of participants prescribed BRIUMVI® (ublituximab-xiiy) in the
real-world setting
For info regarding 2024P000481
please contact Vikrum Singh 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: 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: Cognitive Neurology Unit Clinical Registry
Brief Title: CNU Registry
Brief Summary: A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's
Disease
For info regarding 2023P000494
please contact Daniel Press at 617-667-0459 or
dpress@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: 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: 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: 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: 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: 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