Human Laboratory Study of ANS-6637 for Alcohol Use Disorder Save

Date Added
July 2nd, 2019
PRO Number
Pro00090068
Researcher
Sarah Book

List of Studies


Profiles_link
Keywords
Alcohol, Central Nervous System, Drug Studies, Stage II, Substance Use
Summary

This is a 6-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, ANS-6637, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to take one of two doses of ANS-6637 or a matched placebo.

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-8601
voronin@musc.edu

Development of Wearable Stimulation App to Increase Hand Functional Recovery in Patients with Neurological Movement Save

Date Added
June 4th, 2019
PRO Number
Pro00088976
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

Post-stroke hand impairment diminishes stroke survivors' ability to perform activities of daily living. Motor recovery has been shown to improve through peripheral sensory stimulation. This study aims to determine if vibration from a smartwatch improves post-stroke hand function.

Institution
MUSC
Recruitment Contact
Andrew Fortune
843-792-8970
fortunea@musc.edu

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

Title: Rapid Reversal of CNS-Depressant Drug Effect prior to Brain Death Determination Investigators: Sameh Hanna, MD, Justin Atwood, MD Institution: Palmetto Health-University of South Carolina Medical Group, Division of Pulmonary, Critical Care and Sleep Medicine, Columbia, SC Save

Date Added
December 11th, 2018
PRO Number
Pro00077995
Researcher
Sameh Hanna

List of Studies

Keywords
Brain, Central Nervous System, Nervous System
Summary

Prospective trial with enrollment of 30 patients in various intensive care units at Palmetto Health Richland from January 1st 2019 to June 30th 2020. If patients had undergone targeted temperature management (33-36 degrees Celsius for 24 hours via intravascular or surface control methods, with or without sedation or neuromuscular blockade, followed by rewarming actively or passively at 0.25-0.5 degrees per hour over 8-12 hours to 37 degrees) investigators will wait 24 hours after rewarming prior to testing. End point is to evaluate if pharmacological reversal agents would result in improved GCS scores or return of cerebral or brainstem functions in some comatose patients, which will be considered a positive test result.

Institution
Palmetto
Recruitment Contact
Sameh Hanna
8643443439
sameh.hanna@palmettohealth.org

A Phase 3, Open-Label, Multi-Center Trial to Evaluate the Long-Term Safety and Efficacy of Repeat Treatments of DaxibotulinumtoxinA for Injection in Adults with Isolated Cervical Dystonia (ASPEN-OLS) Save

Date Added
December 11th, 2018
PRO Number
Pro00078648
Researcher
Christine Cooper

List of Studies

Silhouette
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.

If you are eligible and choose to be in the study, the dose of study drug you receive (125 units or 250 units) will depend on your clinical assessment, the severity of your disease, and whether you have had any toxin before.

The study may last up to 55 weeks, including 3 weeks of screening. You will come to the study center up to 15 times.

The study is being done at approximately 80 sites. Approximately 290 adults with moderate to severe isolated CD, who are 18-80 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

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

Silhouette
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

Changes in Optic Nerve Sheath Diameter in Preeclamptic patients with Severe Features by Neurologic Criteria versus Diagnosis Without Neurologic Criteria, Compared to Controls. Save

Date Added
November 7th, 2018
PRO Number
Pro00078977
Researcher
Mary Sterrett

List of Studies

Silhouette
Keywords
Central Nervous System, Hypertension/ High Blood Pressure, Non-interventional, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Preeclamptic patients will have an ultrasound done of their eyes, to look at the size of the nerve behind the eye. We will also recruit women without preeclampsia to be a comparison group.

Institution
MUSC
Recruitment Contact
Mary Sterrett
8434940554
sterretm@musc.edu

Odor Disturbances: Clinical Care Registry Save

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde

List of Studies


Profiles_link
Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@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

Silhouette
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

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 Fletes
843-792-9115
jenkisho@musc.edu

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