Neuroplasticity Associated with Extended Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke Save

Date Added
March 5th, 2019
PRO Number
Pro00086207
Researcher
Na jin Seo

List of Studies


Profiles_link
Keywords
Aging, Central Nervous System, Movement Disorders, Muscle, Nerve, Nervous System, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

The objective is to determine if continuous use of TheraBracelet in the home has a clinically meaningful effect in chronic stroke survivors. The study design is a double-blinded randomized controlled trial. We will enroll 40 chronic stroke survivors with moderate hand impairment. Subjects will be randomly assigned to the treatment or control group (n=20 per group). All subjects will wear the TheraBracelet device on the paretic wrist for 8 hours/day every day during their normal daily activity for 1 month. The device will deliver vibration (treatment) or no vibration (control). Double-blinding is possible because the treatment vibration is imperceptible (i.e., subthreshold). Measures of neural plasticity, the amount of the paretic arm use in daily living, clinical hand function, biomechanical grip control, and self-reported abilities for activities of daily living will be assessed at baseline, once a week during the month of wearing the device, and for 3-month follow-up, allowing determination of the efficacy and persistence.

Institution
MUSC
Recruitment Contact
Amanda Vatinno
843-792-8970
vatinno@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial to Evaluate the Efficacy and Safety of a Single Treatment of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-1) Save

Date Added
November 13th, 2018
PRO Number
Pro00078538
Researcher
Christine Cooper

List of Studies

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Keywords
Central Nervous System, Drug Studies, Movement Disorders, Muscle, Nerve
Summary

The purpose of this study is to evaluate the safety and effectiveness of daxibotulinumtoxinA for injection (a new investigational study drug) compared to placebo in the treatment of cervical dystonia (CD). DaxibotulinumtoxinA for injection is composed of purified botulinum toxin type A, formulated with a small protein RTP004, and will be used for injection. Placebo means it doesn't contain botulinum toxin type A.

If you are eligible and choose to be in the study, the dose of study drug you receive will depend on the group that you will be put into after randomization at the time of your entry.

You will be assigned, by chance, to 1 of the 3 groups below:
? Group 1: High-dose (250 Units of daxibotulinumtoxinA for injection)
? Group 2: Low-dose (125 Units of daxibotulinumtoxinA for injection)
? Group 3: Placebo (a substance that looks like daxibotulinumtoxinA for injection but has no drug in it)

Study lasts aproximately 39 weeks, including 3 weeks of screening. You will come to the study center up to 12 times during the research study.

The study is being done at approximately 80 sites. Approximately 300 people will take part study-wide and 4 will take part at this institution.

Institution
MUSC
Recruitment Contact
Timothy Sheehan
843-792-0372
sheehant@musc.edu

Measurement of gait mechanics and movement in the lower extremity amputee Save

Date Added
October 30th, 2018
PRO Number
Pro00082064
Researcher
Aaron Embry

List of Studies

Keywords
Exercise, Movement Disorders, Physical Therapy, Rehabilitation Studies
Summary

Walking after a lower extremity amputation is often difficult. It is important that researchers and clinicians understand the mechanisms that inhibit normal walking function. In this study, we are recruiting individuals with lower extremity limb loss for a walking and balance investigation. We will also be studying matched healthy controls to do similar study procedures. All study procedures will occur on the campus of MUSC by a licensed Physical Therapist and experienced researcher. Any questions should be directed to the coordinator listed.

Institution
MUSC
Recruitment Contact
Aaron Embry
843-792-8198
embry@musc.edu

Direct measurement of motor cortical responses to transcranial direct current stimulation Save

Date Added
May 15th, 2018
PRO Number
Pro00073545
Researcher
Nathan Rowland

List of Studies

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Keywords
Brain, Central Nervous System, Movement Disorders, Muscle, Nerve, Nervous System, Parkinsons, Surgery
Summary

Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with motor deficits, however its effects have not been consistent in randomized studies to date, limiting widespread adoption of this technology. A critical gap in our knowledge is a detailed understanding of how tDCS affects motor areas in the brain. We propose using tDCS while recording directly from motor cortex using subdural electrocorticography (sECoG) in patients undergoing deep brain stimulation surgery. We expect this novel approach to broaden our understanding of tDCS application and possibly lead to therapeutic advances in this population.

Institution
MUSC
Recruitment Contact
Sanicqua Robinson Smalls
843-792-8553
robinsst@musc.edu

Transcranial magnetic stimulation for modulation of postural control in progressive supranuclear palsy Save

Date Added
April 17th, 2018
PRO Number
Pro00076691
Researcher
Marian Dale

List of Studies

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Keywords
Central Nervous System, Geriatrics, Movement Disorders, Nervous System, Rare Diseases, Rehabilitation Studies
Summary

This research studies the effects of brain stimulation (transcranial magnetic stimulation, or "TMS") on balance in progressive supranuclear palsy (PSP). The purpose of this research is to look for improvements in balance when subjects are on a tilting platform after stimulating the brain with a magnetic wand held over the scalp over an area at the back of the brain called the cerebellum. Participants will receive both active and inactive stimulation during the course of the study. There is no surgery involved. There are also optional portions of the study that include functional magnetic resonance imaging (fMRIs) and speaking samples.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two-Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants with Parkinson's Disease (PD) Save

Date Added
December 19th, 2017
PRO Number
Pro00069638
Researcher
Vanessa Hinson

List of Studies


Profiles_link
Keywords
Drug Studies, Movement Disorders, Parkinsons
Summary

The purpose of this study is to determine if a drug called Nilotinib is safe, if it can be tolerated by patients with PD and to learn if Nilotinib has the possibility of effectively treating PD symptoms. Nilotinib has been approved by the Food and Drug Administration (FDA) to treat certain types of cancer (leukemia) but is considered investigational in this study because it has not been approved for treating PD.

In this study, we are comparing two doses (150mg or 300mg) of Nilotinib to placebo (a pill that looks like the study drug but does not have any active medication in it, like a sugar pill). If you are eligible and choose to be in the study you will be randomly assigned to one of three groups, either:

? 150mg Nilotinib
or
? 300mg Nilotinib
or
? Placebo

All three groups will take two pills of the assigned type each day by mouth. ?Randomly' means that the group you are placed in is determined by chance (like tossing a coin). You will have a 2:1 chance of receiving Nilotinib. Neither you nor the researchers will know whether you are taking Nilotinib or placebo.

About 100 individuals will be interviewed and assessed, and 75 people will be asked to participate in this study at 25 clinics across the United States. Approximately 6 participants will be asked to participate in the study at MUSC.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 (formerly known as BMS-986168) in Participants with Progressive Supranuclear Palsy Save

Date Added
July 25th, 2017
PRO Number
Pro00065914
Researcher
Marian Dale

List of Studies

Silhouette
Keywords
Movement Disorders
Summary

This study will examine how well the study drug, BIIB092 works when compared to a placebo and to study the long-term safety and tolerability of the study drug in subjects with Progressive Supranuclear Palsy (PSP)

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

Validation of computer-based saccade and pupillary light reflex measures as biomarkers for progressive supranuclear palsy Save

Date Added
July 18th, 2017
PRO Number
Pro00065862
Researcher
Marian Dale

List of Studies

Silhouette
Keywords
Aging, Brain, Movement Disorders, Nervous System, Parkinsons, Rare Diseases, Vision/ Eye
Summary

This study examines eye movements and the pupil's response to light in progressive supranuclear palsy (PSP), comparing to Parkinson's disease and control subjects without neurological disease. Computerized measures of eye movements and pupil changes will be used. Subjects will also receive an eye exam to rule out other eye diseases. The goal of this study is to use subtle changes in eye movements and the pupil's response to light for earlier diagnosis of PSP.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-792-9115
jenkisho@musc.edu

Fluid Biomarkers with Deep Phenotyping in Patients with ALS Save

Date Added
June 21st, 2016
PRO Number
Pro00054504
Researcher
Amy Chen

List of Studies

Silhouette
Keywords
Movement Disorders, Muscle, Nervous System
Summary

You are invited to volunteer for a research study if you have been diagnosed with Amyotrophic Lateral Sclerosis (ALS) within 2 years (24 Months) prior to screening.

This is a non interventional, longitudinal study in patients with ALS. There will be four (4) subject visits in this study: Baseline, month 6, month 12, and month 18. Subjects will have blood and cerebrospinal fluid (a clear fluid found in your brain and spine) collected, and be evaluated with assessment tools that focus on upper and lower motor skills and strength as well as cognitive function. Researchers will use these samples to study ALS, motor neuron disease and other medical conditions.

Institution
MUSC
Recruitment Contact
Christine Hudson
843-792-3790
hudsoncm@musc.edu

An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Save

Date Added
January 26th, 2016
PRO Number
Pro00048197
Researcher
Christine Cooper

List of Studies

Silhouette
Keywords
Movement Disorders, Parkinsons
Summary

This is a prospective, multi-center, open-label, Phase 3 study in Levodopa responsive PD patients with motor fluctuations, designed to evaluate the long-term safety, tolerability and efficacy of APL-130277. APL-130277 is being evaluated as a "rescue" treatment for OFF episodes.

The overall number of subjects is not pre-specified as this is an extension
study.

Patients who have completed any of the following studies: CTH-201,
CTH-203, CTH-300, CTH-301, or CTH-302 will be eligible to enroll into
this study. In addition, approximately one hundred (100) de novo patients
will also be enrolled.

Institution
MUSC
Recruitment Contact
Shonna Jenkins
843-795-9115
jenkisho@musc.edu

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