Status:
RECRUITING
Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
Lead Sponsor:
University of Washington
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
Brief Summary
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) rep...
Eligibility Criteria
Inclusion
- Diagnosis of MS
- Age between 21 and 70
- Presence of upper extremity functional impairment (correlating with raw score ≤34 on NeuroQOL Upper Extremity Function short-form questionnaire),
- Ability to attend intervention and assessment sessions 3 times per week.
- For women of childbearing potential, willingness to provide confirmation of a negative over-the-counter home pregnancy test within 2 weeks of study entry and prior to each intervention arm.
Exclusion
- Relapse within the past 6 months (given that natural recovery from relapse could skew results)
- Active implanted stimulator or baclofen pump
- Upper extremity botox injection within the past 6 months
- Unstable dalfampridine usage during study duration (which may interfere with functional outcomes)
- Coexisting neurological condition that could interfere with interpretation of testing results (hx of stroke, traumatic brain injury, epilepsy/seizure, ALS, spinal cord injury, central nervous system vasculitis, intracranial tumor, intracranial aneurysm, cervical myelopathy/radiculopathy or peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy), etc.)
- History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia
- Serious comorbidities (e.g., cardiac arrhythmia, uncontrolled hypertension, respiratory disease, cancer, renal failure, chronic infectious disease, rheumatic disease, frequent UTIs, etc.) that would prevent participation in study activities
- Presence of severe joint contractures in the affected hand and arm that may interfere with study activities or outcome measures
- Severe spasticity, as defined by an Ashworth score of 4 in both sides of the upper limb
- Pregnant and/or breastfeeding
- Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment
- Inability to give consent
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06552611
Start Date
August 8 2024
End Date
July 1 2025
Last Update
August 14 2024
Active Locations (1)
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1
University of Washington
Seattle, Washington, United States, 98133