For more information, visit our Neurology Program
Return to Non-Cancer Program Name Search
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: 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: Mechanisms Of Orbitofrontal stimulation in Depression (MOOD)
Brief Title: Mechanisms Of Orbitofrontal stimulation in Depression (MOOD)
Brief Summary: The orbitofrontal cortex (OFC), a region involved in emotional regulation, decision
making, and reward processing, is a key area linked to antidepressant response. This
study tests whether noninvasive stimulation of the OFC using transcranial magnetic
stimulation (TMS) can improve depressive symptoms. TMS uses magnetic fields generated by
a coil placed next to the scalp to alter brain activity.
For info regarding 2025P000673
please contact Subha Subramanian at 617-667-2702 or
ssubram5@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: 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: A Phase II, 26-week, double-blind, placebo-controlled study to assess the safety, tolerability,
pharmacokinetics, and efficacy of ONO-2020 in patients with mild to moderate Alzheimer’s
Disease
Brief Title: A Phase II study to assess the safety, tolerability, pharmac
Brief Summary: This is a Phase 2, double-blind, parallel-group, placebo-controlled study to assess
safety, tolerability, pharmacokinetics, and efficacy of ONO-2020 in participants with
mild to moderate Alzheimer's disease (AD). This study aims to determine whether
administering ONO-2020, an epigenetic regulator, may improve cognitive functions like
memory and cognition in individuals with Alzheimer's disease dementia.
For info regarding 2025P000361
please contact Daniel Press at 617-667-0459 or
dpress@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: Interventional, randomized, double-blind, placebo-controlled, optional open-label extension trial of Lu AF82422 in participants with Multiple System Atrophy
Brief Title: Lu AF82422 – Phase III clinical trial for MSA (MASCOT)
Brief Summary: The main goal of this trial is to evaluate the efficacy and safety of amlenetug for the
treatment of participants with Multiple System Atrophy (MSA).
For info regarding 2025P000043
please contact Roy Freeman at 617-632-8454 or
rfreeman@bidmc.harvard.edu
Title: A Phase 2 Double-Blind Placebo-Controlled Single-Dose Study of Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of REGN7544, an NPR1 Antagonist Monoclonal Antibody, in Patients with Postural Orthostatic Tachycardia Syndrome
Brief Title: Phase 2 NPR1 Antagonist in Patients with POTS
Brief Summary: This study is researching an experimental drug called REGN7544 (called "study drug"). The
study is focused on participants with POTS.
The aim of the study is to see how safe, tolerable, and effective the study drug is.
The study is looking at several other research questions, including:
- How the study drug changes heart rate and blood pressure in participants with POTS
- What side effects may happen from taking the study drug
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study
drug less effective or could lead to side effects)
For info regarding 2025P000042
please contact Roy Freeman at 617-632-8454 or
rfreeman@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: 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
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.
Participants will:
• Take NEU-411 or placebo every day for 52 weeks
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
Brief Summary: This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled,
parallel-group study, followed by an OLE, is designed to evaluate the safety,
tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD.
LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or
homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
For info regarding 2024P000639
please contact Hannah Babcock at 617-667-9890 or
hbabcock@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)
Brief Summary: The purpose of each study is to independently measure the annualized relapse rate (ARR)
with administration of frexalimab compared to a daily oral dose of teriflunomide in male
and female participants with relapsing forms of multiple sclerosis (aged 18 to 55 years
at the time of enrollment). People diagnosed with relapsing forms of multiple sclerosis
are eligible for enrollment as long as they meet all the inclusion criteria and none of
the exclusion criteria.
Study details include:
- This event-driven study will have variable duration depending on the recruitment
rate, the event rate, the study discontinuation rate and the 12-month minimum
treatment duration. Different participants will have different study durations. The
last participant randomized will have at least 12 months of study duration, and
assuming a 28-month recruitment period, the first participant randomized will have
40 months or longer of study duration.
- The study intervention duration will vary similarly as the study duration.
- The assessment of scheduled visits will include 1 common end of study [EOS] visit
and 3 follow-up visits) with a visit frequency of every 4 weeks for the first 6
months and then every 3 months.
For info regarding 2024P000493
please contact Jacob Sloane, MD at 617-667-3726 or
vsingh4@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: 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: 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: 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 Proof of Concept Trial of a Sirtuin-NAD+ Activator in Alzheimer’s Disease
Brief Title: MIB - AD
Brief Summary: The investigational product, MIB-626, which is not FDA approved, is being studied for its ability to treat or prevent Alzheimers Disease. As a first step we want to find out if MIB-626 can get into the brain and increase the levels of a related chemical in parts of the brain that are affected in Alzheimers Disease. We also want to make sure that MIB-626 is safe to take without causing too many side effects.
For info regarding 2023C001160
please contact Daniel Press at 617-667-0459 or
dpress@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: 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: 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: 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