Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
NCT Number: NCT06552611
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Multiple Sclerosis
Interventions: COMBINATION_PRODUCT: Transcutaneous electrical spinal cord stimulation + therapy|OTHER: Occupational Therapy
Sponsor: University of Washington
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 4
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2025-07-01
Locations: University of Washington, Seattle, Washington, 98133, United States

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) 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

Primary Outcome Measures: Nine-Hole Peg Test, Nine-Hole Peg Test is a standardized, quantitative assessment used to measure finger dexterity. Score is time it takes to complete task (range 15-180 seconds). Higher score = worse outcome., 6 weeks|NeuroQoL Upper Extremity Function, A self-report of health-related quality of life for adults with neurological disorders. Score ranges from 8-40; higher score = better function, 6 weeks|Participant Drop-out rate, Percentage of participants who complete the intervention protocol. (0-100%), 6 weeks
Secondary Outcome Measures: Action Research Arm Test, A 19-item clinician-administered observational measure to assess upper extremity performance (coordination, dexterity, and functioning). Items comprising the ARAT are categorized into four subscales (grasp: 6 items, score 0-18; grip: 4 items, score 0-12; pinch: 6 items, score 0-18; and gross movement: 3 items, score 0-9) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Scores are aggregated to a final scale (ranging from 0-57); Higher scores indicate better performance., 6 weeks|Box and Blocks Test, Measures unilateral gross manual dexterity. The test kit comprises a wooden box divided into two compartments by a partition and 150 blocks. Participants move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds. Score ranges from 0-150; higher score indicates better function., 6 weeks|Grip force, measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-200); higher score indicates better function., 6 weeks|Pinch force, measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-100); higher score indicates better function., 6 weeks|Modified Ashworth Scale, A clinician-administered test for resistance of a joint to the passive movement. This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity). Higher score indicates worse function, 6 weeks|Patient-reported Impact of Spasticity Measure, A patient-reported outcome questionnaire assessing the impact of spasticity on function and quality of life over the past week. Score ranges from 0-164; higher scores indicate worse function., 6 weeks|Modified Fatigue Impact Scale, A patient-reported outcome questionnaire. It is a modified form of the Fatigue Impact Scale based on items derived from interviews with multiple sclerosis patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue on physical, cognitive, and psychosocial functioning. Score ranges from 0-84; higher score indicates worse function., 6 weeks|PROMIS Pain Interference, A patient-reported outcome questionnaire that measures the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Score ranges from 4-20; higher score indicates worse function., 6 weeks|PROMIS Pain Intensity, A patient-reported outcome numeric rating scale of pain over the past 7 days. Score ranges from0-10; higher score indicates worse pain, 6 weeks|Bowel Control Scale, A patient-reported outcome questionnaire for bowel management. This is a subsection of the Multiple Sclerosis Quality of Life Inventory. Score ranges from 0-26; higher score indicates worse function., 6 weeks|Bladder Control Scale, A patient-reported outcome questionnaire for bladder management. This is a subsection of the Multiple Sclerosis Quality of Life Inventory. Score ranges from 0-22; higher score indicates worse function., 6 weeks|Global Impression of Change, A patient and clinician-reported scale of change pre- to post-intervention, ranging from 1 (indicating "very much improved") to 7 (indicating "very much worse")., 6 weeks|Ability to Participate in Social Roles and Activities, A self-report of health-related quality of life in 17 domains and sub-domains for adults with neurological disorders. Score ranges from 4-40; higher scores indicates better function., 6 weeks