A PHASE 3, MULTICENTER, OPEN-LABEL SAFETY STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF SAGE-718 IN PARTICIPANTS WITH HUNTINGTON'S DISEASE

Date Added
May 4th, 2023
PRO Number
Pro00125656
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Movement Disorders
Summary

This study is an open-label study that will evaluate SAGE-718 on the cognitive effects in subject with early manifest Huntington's Disease (HD). The subject will be on study drug for a year. At clinic visits, participants will take the IP under staff supervision, followed by assessments of cognitive function, health-related function and quality of life, and neuropsychiatric symptoms.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

Extending taVNS Paired with Infant CIMT into a Home-Based Setting: Technology Development Requisite for a Randomized Trial

Date Added
January 3rd, 2023
PRO Number
Pro00123579
Researcher
Kelly McGloon

List of Studies

Keywords
Brain, Infant, Movement Disorders, Physical Therapy, Stroke Recovery
Summary

Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. taVNS stimulation will be triggered by EMG sensors which detect muscle activity. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-24 months of age.

Institution
MUSC
Recruitment Contact
Kelly McGloon
8437926443
mclgoon@musc.edu

A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for the Treatment of Upper Limb Essential Tremor

Date Added
October 11th, 2022
PRO Number
Pro00122311
Researcher
Christine Cooper

List of Studies


Keywords
Movement Disorders
Summary

The purpose of this study is to see if the study drug BOTOX®, is safe and helps to reduce upper limb essential tremor in adults who experience persistent tremor during movement. The study is 38 weeks long and includes 12 clinic visits. Participants will be injected with the study drug or placebo 3 times over the 38 week period. The participant will have to complete a set of questionnaires and assessments at each visit.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants with Huntington's Disease

Date Added
March 3rd, 2022
PRO Number
Pro00116394
Researcher
Federico Rodriguez-Porcel

List of Studies


Keywords
Movement Disorders
Summary

This study will test SAGE-718 to evaluate cognitive effects in subject with early manifest HD. The subject will be on study drug or placebo for 84 days. At clinic visits, participants will take the IP under staff supervision, followed
by assessments of cognitive function, health-related function and quality of life, and neuropsychiatric symptoms.

Institution
MUSC
Recruitment Contact
Sandra Wilson
843-792-4616
wilsosan@musc.edu

Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

Date Added
August 26th, 2021
PRO Number
Pro00111341
Researcher
Cynthia Dodds

List of Studies


Keywords
Brain, Infant, Movement Disorders, Pediatrics, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Constraint-induced movement therapy (CIMT) is the most efficacious treatment for children with hemiparesis from a perinatal arterial stroke but instead, weekly low-dose OT and/or PT is typical. The aims of this study are to compare 2 high doses of treatment to usual care in helping infants improve skills on the hemiplegic hand/arm and to improve bimanual activities. In addition, the association with gross motor, language and cognition will be explored.

Institution
MUSC
Recruitment Contact
Patricia Coker-Bolt
843-792-7491
cokerpc@musc.edu

Combined Deep Brain Stimulation and Functional Magnetic Resonance Imaging

Date Added
July 20th, 2021
PRO Number
Pro00111668
Researcher
Gonzalo Revuelta

List of Studies


Keywords
Brain, Movement Disorders, Parkinsons
Summary

The purpose of this research study is to identify brain activation patterns in response to deep brain stimulation (DBS). To participate in this study, participants are required to have had a DBS implant or to be healthy controls without a history of a neurological disorder. Participants will undergo screening, a motor assessment session and a 30-minute Magnetic Resonance Imaging (MRI) session where their DBS device will be turned on and off in a cycled pattern. This study will be separated over 3 visits (Visit 1 for screening, Visit 2 for motor assessments and Visit 3 for the MRI scans). The total study duration will be approximately 5 hours.

Institution
MUSC
Recruitment Contact
Daniel Lench
843-792-9115
lenchd@musc.edu

Combining taVNS with early CIMT to improve health outcomes of infants

Date Added
May 4th, 2021
PRO Number
Pro00109558
Researcher
Dorothea Jenkins

List of Studies


Keywords
Brain, Infant, Movement Disorders, Physical Therapy, Stroke Recovery
Summary

Newborns who are born premature or suffer brain injury at birth are at risk for motor problems that may cause weakness in reaching and grasping on one side of the body. In older children, therapists may use a hand mitt and restraint for the stronger arm, to encourage use of the weaker side, called constraint-induced movement therapy (CIMT). Even with the high intensity therapy of CIMT, it typically takes between 40-120 hours total treatment time for most children to improve their motor skills. A non-invasive form of nerve stimulation, transcutaneous auricular vagus nerve stimulation (taVNS), stimulates a nerve by the ear that enhances learning motor skills. The purpose of this study is to evaluate the safety and effectiveness of taVNS to improve motor skills when paired with CIMT in infants with one-sided weakness at 6-18months of age.

Institution
MUSC
Recruitment Contact
Patricia Coker-Bolt
843-792-7491
coerkpc@musc.edu

Operant Conditioning of Spinal Reflexes to Enhance Motor Function Recovery after Spinal Cord injury

Date Added
April 7th, 2020
PRO Number
Pro00095583
Researcher
Aiko Thompson

List of Studies


Keywords
Central Nervous System, Movement Disorders, Rehabilitation Studies, Spinal Cord
Summary

The purpose of the first portion of this study is to gather feedback from clinicians on the usability of the current system and procedure, so the researchers can make reflex training more useful and usable for improving recovery after spinal cord injury or other nervous system injuries and diseases. The researchers are recruiting 20 therapists who have been actively practicing physical medicine and 30 adults with no known neurological conditions to test system usability and the reflex operant conditioning protocol. For this portion of the study, there are 5 visits. We will also recruit 15 adults with no neurological injuries, 15 adults with neuropathic pain, and 15 adults with non-neuropathic pain to participate in one visit to provide feedback on sensation caused by stimulating electrodes.

The purpose of the second part of the study is to validate the capacity of the system to change the size of the targeted reflex. For this the researchers are recruiting 25 individuals with chronic incomplete SCI who have spasticity in the leg to participate in the reflex training procedure. The study involves approximately 45 visits with a total study duration of about 6 months.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@musc.edu

Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke

Date Added
August 6th, 2019
PRO Number
Pro00090790
Researcher
Na Jin Seo

List of Studies


Keywords
Aging, Exercise, Movement Disorders, Nervous System, Physical Therapy, Stroke, Stroke Recovery
Summary

Hand disability after stroke has a profound negative impact on functional ability and independence. Hand therapy may be augmented with sensory stimulation for better outcomes. We have developed a novel sensory stimulation - unfelt vibration applied via a wristwatch. In this study, we will determine if combining this stimulation with hand task practice is superior to hand task practice alone.

Institution
MUSC
Recruitment Contact
Na Jin Seo
8437920084
seon@musc.edu

Measurement of gait mechanics and movement in the lower extremity amputee

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



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