Effect of Mexiletine on Cortical Hyperexcitability in Sporadic Amyotrophic Lateral Sclerosis (SALS) Save

Date Added
April 18th, 2017
PRO Number
Pro00064552
Researcher
Amy Chen

Silhouette
Keywords
Muscle, Nervous System
Summary

The primary study objective is to determine whether treatment with mexiletine at doses of 300 mg/day or 600 mg/day suppresses cortical hyperexcitability in sporadic ALS patients relative to placebo, and, thus, may be able to slow progression in ALS. The change in resting motor threshold (RMT), estimated from single pulse transcranial magnetic stimulation (TMS) measurements made before treatment, after 4 weeks of treatment, and then again after a 4 week washout, will be used as the primary pharmacodynamic marker of cortical hyperexcitability.

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

TheraBracelet: The first and only wearable to instantly improve stroke hand function Save

Date Added
January 3rd, 2017
PRO Number
Pro00062471
Researcher
Na jin Seo

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

Post-stroke hand impairment is highly prevalent and severely restricts functional ability and independence. Yet, there is no assistive device to help hand function at home, every day, during activities of daily living. This study addresses this gap by providing an innovative technology. The "TheraBracelet" is a wristband applying imperceptible white-noise vibration to skin. TheraBracelet is efficacious, as it has been shown to immediately improve chronic stroke survivors' touch sensation and hand dexterity in preliminary studies. TheraBracelet is affordable by using only a low-cost vibrator. TheraBracelet is also translational, because a vibrator strategically placed at the wrist does not interfere with dexterous finger motions, and it is low-risk by involving only imperceptible vibration on skin. These practicalities assure easy adoption in home environment for large impact on sensorimotor impairment. This study is to determine the feasibility and safety of using this assistive device all day every day for a month during daily activity, and to determine if TheraBracelet's instant effects are sustained during prolonged use. This objective will be accomplished in a double-blinded, randomized, controlled, crossover design study. Feasibility (compliance of using the device everyday) and safety will be assessed for the treatment condition compared to the control condition (wearing the device without vibration) through weekly evaluations. In addition, TheraBracelet's instant benefits in improving hand function will be assessed weekly. Persistence of TheraBracelet's instant benefits across all weekly evaluations will support durability (i.e. desensitization to vibration does not occur during extended daily use over a one-month period). This project is expected to lead to an assistive wristband that increases hand function during activities of daily living, thus increasing independence and quality of life and reducing caregiver burden for a large number of stroke survivors with hand impairment.

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

Operant conditioning of spinal reflexes in healthy people and people with neurological disorders. Save

Date Added
November 23rd, 2016
PRO Number
Pro00060769
Researcher
Richard Segal

Silhouette
Keywords
Body Composition, Healthy Volunteer Studies, Movement Disorders, Muscle, Nerve, Nervous System, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Our long term goal is to enhance the locomotion of impaired individuals after a neurological injury.
We are trying to recruit as healthy control participants, and neurologically impaired individuals (incomplete SCI and after-stroke patients) to participate in this study.
For neurologically impaired individuals a physical therapist will complete IRB approved questionnaires to measure your mobility, muscle strength, balance, walking speed, and distance.
All participants will meet with study staff who would then test your reflexes by placing some superficial skin based electrodes behind the knee and apply mild stimulation while standing/sitting.
If enrolled, you may be required to participate for 30 sessions (3 sessions/week), each lasting about one hour over a period of 3 months. Compensation is available for your participation.

Institution
MUSC
Recruitment Contact
Aviroop Dutt-Mazumder
843-792-0275
duttamaz@musc.edu

Fluid Biomarkers with Deep Phenotyping in Patients with ALS Save

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

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

Mechanisms Underlying Recovery Response to Gait Perturbation Post-Stroke Save

Date Added
May 3rd, 2016
PRO Number
Pro00053690
Researcher
Shraddha Srivastava

Silhouette
Keywords
Brain, Movement Disorders, Muscle, Stroke
Summary

The purpose of this study is to identify the differences between stroke survivors and healthy individuals' response to balance perturbation during walking for example tripping while walking and to evaluate the effects of non-invasive brain stimulation known as bihemispheric transcranial direct current stimulation (tDCS) on balance recovery during walking in stroke survivors.

Institution
MUSC
Recruitment Contact
Shraddha Srivastava
843-792-6165
srivasts@musc.edu

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with Dermatomyositis. Save

Date Added
April 26th, 2016
PRO Number
Pro00054009
Researcher
Katherine Ruzhansky

Silhouette
Keywords
Drug Studies, Inflammation, Muscle, Rare Diseases, Skin
Summary

Subjects are being asked to volunteer for this research study because they have been diagnosed with Dermatomyositis (DM). This study will test the safety and effectiveness of the investigational new drug, IMO-8400. Subjects will receive a subcutaneous injection of the study drug or placebo once a week for up to 24 weeks during the study. Subjects will complete a total of 27 visits over the course of 32 weeks. After the baseline visit, subjects will have the option of having a visiting nurse (who has been trained in the protocol and approved by the Sponsor) conduct the intervening weekly study visits 2-25 outside of the clinic (e.g., at your home or workplace) rather than coming in to clinic for injections.

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

The effects of impaired post-stroke coordination and motor pathway integrity on mobility performance Save

Date Added
November 6th, 2015
PRO Number
Pro00048394
Researcher
Steven Kautz

Silhouette
Keywords
Healthy Volunteer Studies, Military, Muscle, Physical Therapy, Rehabilitation Studies, Stroke Recovery
Summary

Walking is important to persons who have had a stroke and better rehabilitation methods are needed to restore or improve their walking. This project will investigate ways to improve upon and diagnose the specific underlying impairments. Future work will allow clinicians, such as physicians and physical therapists, to make measurements in their clinic to better diagnose a person's specific walking deficit, design a specific treatment plan, and monitor its ability to restore or improve the person's walking.

Institution
MUSC
Recruitment Contact
Landi Wilson
843-792-9013
Wilsolan@musc.edu

Assessment of Contributions to Impaired Walking after Neurologic Injury Save

Date Added
January 15th, 2014
PRO Number
Pro00028941
Researcher
Mark Bowden

Silhouette
Keywords
Brain, Healthy Volunteer Studies, Muscle, Nerve, Physical Therapy, Rehabilitation Studies, Stroke
Summary

Rehabilitation interventions including resistance training, functional and task-specific therapy, and gait or locomotor training have been shown to be successful in improving motor function in individuals with neurologic disease or injury. Recent investigations conducted in our laboratory indicate that intense resistance training coupled with task-specific functional training lead to significant gains in functional motor recovery. Similarly, gait rehabilitation involving intense treadmill training and/or task-specific locomotor training has been shown to be effective in improving locomotor ability. However, the underlying neural adaptations associated with these therapeutic approaches are not well understood. Our primary goal is to understand the motor control underpinnings of neurologic rehabilitation in order to apply this knowledge to future generations of therapeutic interventions.

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

Psycho?social and quality-of-life impact of chemodenervation in patients with unilateral facial paresis. Save

Date Added
November 17th, 2013
PRO Number
Pro00025742
Researcher
Krishna Patel

Silhouette
Keywords
Muscle, Nerve
Summary

This study will be a chart review and FaCE questionnaire developed for patients who have undergone chemodenervation for unilateral facial paresis. Patients who come in to the PI's clinic and undergo chemodenervation clinically until 2016 will be included. We anticipate that this cohort will include approximately 50 patients ranging in age from 18 to 85. Information collected will include patient name, MRN, diagnosis, dates of therapy, comorbidities, gender, race questionnaire results-drinking from a cup, ability to make specific sounds, ability to keep food in mouth, eye tearing, difficulty brushing teeth, isolating themselves, calmness, irritability with others, social activities, tension/pain/spasms on affected side of face, ability to move face (pucker lips, smile raise eyebrows), treatment by others. The effects of chemodenervation gradually decrease over several months after administration, which requires a continuous readministration as needed. Questionnaire will be delivered prior to chemodenervation and after chemodenervation. Each patient will be asked to undergo the study process(pre- and post- survey) through one chemodenervation treatment randomly. The pre-treatment questionnaire will be filled out in writing prior to the procedure in clinic. Then, approximately 2-6 weeks post-injection, the patients will be called and asked to conduct the same questionnaire verbally over the phone as a post-treatment survey. The data will be collected, deidentified and stored in an Excel spreadsheet for analysis. Analysis will involve assessing if patients have improved functionality and quality of life for undergoing chemodenervation. Chemodenervation is a standard treatment these patients routinely undergo. Study is only adding a survey to assess the outcomes from the patients perspective.

Institution
MUSC
Recruitment Contact
Krishna Patel
843-876-0922
patelkg@musc.edu

Skeletal Muscle Plasticity As An Indicator of Functional Performance Post Stroke Save

Date Added
August 12th, 2013
PRO Number
Pro00025988
Researcher
Chris Gregory

Silhouette
Keywords
Exercise, Muscle, Stroke
Summary

Weakness on one side of the body is seen in three-quarters of individuals following stroke. Weakness in this population results from both neural and muscular factors which include, respectively, the ability of the central nervous system to activate skeletal muscle as well as the force generating capacity of the muscle. Our overall goal is to improve walking in persons post-stroke by training subjects with an intervention that specifically targets these impairments, thereby facilitating locomotor recovery.

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

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