Actively Recruiting
Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
Led by University of Washington · Updated on 2024-08-14
4
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Current disease-modifying therapies for multiple sclerosis (MS) aim to prevent the development of new lesions; unfortunately, no current FDA-approved therapies promote central nervous system (CNS) repair mechanisms. Thus, strategies to promote functional recovery from lesion-related deficits in adults with MS remain an unmet need. This is a pilot study designed to test the feasibility, safety and preliminary efficacy of non-invasive (transcutaneous, applied by surface electrodes over the skin) electrical spinal cord stimulation combined with occupational therapy for restoring upper extremity sensorimotor function in adults with multiple sclerosis. Participants with multiple sclerosis and impaired upper extremity function will complete two separate 6-week intervention sessions: 6 weeks of occupational therapy combined with transcutaneous spinal cord stimulation and 6 weeks of occupational therapy alone. The order of these interventions will be randomized, and each intervention will be separated by a 6-week washout period. The investigators hypothesize that: 1. transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants 2. transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone 3. transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life (pain, spasticity, and bladder symptoms) compared to occupational therapy alone
CONDITIONS
Official Title
Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple sclerosis
- Age between 21 and 70 years
- Upper extremity functional impairment with a NeuroQoL Upper Extremity Function score of 34 or less
- Ability to attend intervention and assessment sessions three times per week
- For women of childbearing potential, willingness to provide a negative pregnancy test before each intervention period
You will not qualify if you...
- Relapse of multiple sclerosis within the past 6 months
- Presence of active implanted stimulator or baclofen pump
- Botox injection in upper extremity within past 6 months
- Unstable use of dalfampridine during the study
- Other neurological conditions that could affect test results (e.g., stroke, brain injury, epilepsy, ALS, spinal cord injury)
- History of major psychiatric illness such as severe depression, substance abuse, or dementia
- Serious medical conditions that prevent study participation (e.g., heart arrhythmia, uncontrolled hypertension, respiratory disease, cancer, kidney failure, chronic infections, rheumatic disease, frequent urinary infections)
- Severe joint contractures in the affected hand or arm
- Severe spasticity (Ashworth score of 4) in both upper limbs
- Pregnancy or breastfeeding
- Inability to understand, cooperate, or safely perform study procedures
- Inability to provide informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98133
Actively Recruiting
Research Team
S
Sarah Simmons, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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