Non-invasive electrical stimulation to improve arm function in multiple sclerosis
Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
This study is testing whether using non-invasive electrical stimulation along with occupational therapy can help improve arm function in adults with multiple sclerosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 4 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06552611 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility, safety, and preliminary efficacy of non-invasive electrical spinal cord stimulation combined with occupational therapy for adults with multiple sclerosis who have impaired upper extremity function. Participants will undergo two 6-week intervention sessions, one involving spinal cord stimulation and occupational therapy, and the other involving occupational therapy alone, with the order of interventions randomized. The study seeks to address the unmet need for therapies that promote functional recovery in MS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 70 with a diagnosis of multiple sclerosis and significant upper extremity functional impairment.
Not a fit: Patients who have experienced a relapse in the past 6 months or have certain neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance upper extremity function in patients with multiple sclerosis, improving their quality of life.
How similar studies have performed: While this approach is novel, other studies have explored neuromodulation techniques for rehabilitation, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of MS 2. Age between 21 and 70 3. Presence of upper extremity functional impairment (correlating with raw score ≤34 on NeuroQOL Upper Extremity Function short-form questionnaire), 4. Ability to attend intervention and assessment sessions 3 times per week. 5. 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 Criteria: 1. Relapse within the past 6 months (given that natural recovery from relapse could skew results) 2. Active implanted stimulator or baclofen pump 3. Upper extremity botox injection within the past 6 months 4. Unstable dalfampridine usage during study duration (which may interfere with functional outcomes) 5. 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.) 6. History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia 7. 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 8. Presence of severe joint contractures in the affected hand and arm that may interfere with study activities or outcome measures 9. Severe spasticity, as defined by an Ashworth score of 4 in both sides of the upper limb 10. Pregnant and/or breastfeeding 11. Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment 12. Inability to give consent
Where this trial is running
Seattle, Washington
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Sarah Simmons, MD, PhD — University of Washington
- Study coordinator: Sarah Simmons, MD, PhD
- Email: sbs2@uw.edu
- Phone: 206-356-6352
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.