ATHN 9: A Natural History Cohort Study of the Safety, Effectiveness, and Practice of Treatment for People With Severe Von Willebrand Disease (VWD) Save

Date Added
January 27th, 2020
PRO Number
Pro00092790
Researcher
Stephanie Ambrose

List of Studies

Keywords
Adolescents, Blood Disorders, Children's Health, Circulation, Dental, Genetics, Infant, Joint, Men's Health, Minorities, Muscle, Non-interventional, Nose, Obstetrics and Gynecology, Pain, Pediatrics, Periodontal Disease, Rare Diseases, Rheumatoid, Surgery, Women's Health
Summary

ATHN 9 is a natural history study to assess the safety of various Von Willebrand Factor (VWF) regimens for different indications (on-demand, surgery and prophylaxis) in adult and pediatric participants with clinically severe congenital VWD.

Institution
Palmetto
Recruitment Contact
Shannon Cearley
803-434-4088
shannon.cearley@prismahealth.org

Neuromodulation of motor and sensory spinal pathways in subjects undergoing epidural spinal cord stimulation. Save

Date Added
October 15th, 2019
PRO Number
Pro00089881
Researcher
Nathan Rowland

List of Studies

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Keywords
Central Nervous System, Muscle, Nerve, Nervous System, Pain, Spinal Cord
Summary

Spinal cord stimulation (SCS) therapy is currently used to treat the symptoms of chronic pain. Studying the effect of SCS during muscle testing, proprioception testing and multiple gait analysis, we expect to gain understanding of exactly how SCS influences motor and sensory pathways of the spinal cord. We expect this approach to broaden our understanding in the application of SCS in the chronic pain conditions, and may lead to therapeutic advances in other populations, for example, patients with spinal cord injury.

Institution
MUSC
Recruitment Contact
Taylor Mayberry
5024423087
mayberrt@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis Save

Date Added
September 24th, 2019
PRO Number
Pro00092083
Researcher
Amy Chen

List of Studies

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Keywords
Muscle, Nervous System
Summary

Myasthenia gravis (MG) is a serious, sometimes life threatening, debilitating condition associated with numerous symptoms including muscular weakness and fatigue. This study is to see how effective and safe rozanolixizumab is in adult patients experiencing moderate to severe symptoms of generalized myasthenia gravis (gMG).

The study consists of a Screening Period of up to 4 weeks, followed by a 6-week double-blind Treatment Period and an Observation Period of 8 weeks. During this 18 weeks period there will be 14 visits to the study clinic.

Institution
MUSC
Recruitment Contact
Aparna Choudhury
843-792-7450
choudhur@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

HELIOS-A: A Phase 3 Global, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ALN-TTRSC02 in Patients with Hereditary Transthyretin Amyloidosis (hATTR Amyloidosis) Save

Date Added
May 14th, 2019
PRO Number
Pro00088330
Researcher
Katherine Ruzhansky

List of Studies

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Keywords
Muscle, Nervous System, Rare Diseases
Summary

This is a global phase 3 open-label study designed to evaluate the efficacy and safety of ALN-TTRSC02 in adult patients (18 - 85 years of age) with hATTR amyloidosis. The estimated time on the study is approximately 3 years, including 42 days of Screening, an 18 month Treatment Period and an 18 month Treatment Extension Period.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
kellej@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

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

PROMISE-MG: Prospective Multicenter Observational Cohort Study of Comparative Effectiveness of Disease-Modifying Treatments for Myasthenia Gravis Save

Date Added
September 24th, 2018
PRO Number
Pro00077927
Researcher
Katherine Ruzhansky

List of Studies

Silhouette
Keywords
Muscle, Nervous System
Summary

This is an observational study to develop a research registry to collect information from subjects with Myasthenia Gravis (MG) to evaluate the effects of the treatments they receive and to understand how their medical condition and treatment affects their daily life.

Institution
MUSC
Recruitment Contact
Katrina Madden
843-792-9186
maddenka@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

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

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