Home-based Spinal Cord Stimulation for Hand & Arm Function in MS

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07673354
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Spinal Cord Stimulation + Hand/arm Exercises — COMBINATION_PRODUCT
    A two-channel transcutaneous spinal cord stimulator (SCONE, SpineX, Inc.) will deliver non-invasive electrical stimulation during hand/arm exercise sessions. For each session, two self-adhesive hydrogel electrodes will be positioned along the midline of the C3-C4 and C6-C7 spinous processes over the skin. The electrical current employed for the transcutaneous spinal cord stimulation is biphasic, featuring a 1-millisecond pulse width, a base frequency of 30 Hz, and an overlapping frequency of 10 kHz. Stimulation intensity will be individualized for each participant, up to a maximum of 120 milliamperes (mA). The hand/arm exercise program is comprised of intensive, progressive, functional task practice following a standardized protocol. The protocol consists of repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance.

Study Details

This is a pilot study designed to test the feasibility of in-home, non-invasive (transcutaneous, applied by surface electrodes over the skin) electrical spinal cord stimulation combined with exercises for restoring upper extremity sensorimotor function in adults with multiple sclerosis. Participants with multiple sclerosis and impaired upper extremity function will complete 8-weeks of hand/arm exercises combined with spinal cord stimulation performed at home with the help of a partner. The investigators hypothesize that: 1. in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will be feasible and acceptable by participants 2. in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will lead to improvements in upper extremity function after 8-weeks 3. in-home transcutaneous spinal cord stimulation combined with therapy will lead to improvements in symptoms related to quality of life (pain, spasticity, and bladder symptoms)

Key Dates

Start date
Jul 16, 2026
Status verified
Jun 2026
Primary completion
Mar 1, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
2 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Home Exercise + Spinal Cord Stimulation
    The 8-week intervention will consist of approximately 1-hour sessions, 3-4x times per week. These sessions will occur in the participant's home, during which hand/arm exercises and transcutaneous spinal cord stimulation (tSCS) will be performed. A caregiver or partner will assist with electrode placement and tSCS administration. Exercises are similar to what would be prescribed by an occupational therapist for an outpatient home exercise program, and include: repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance.

Primary Outcome Measure

Retention rate [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98195-

Find similar trials in Seattle, WA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
University of Washington· Seattle, WA

Related Studies