Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT06552611
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Transcutaneous electrical spinal cord stimulation + therapy — COMBINATION_PRODUCT
    A two-channel transcutaneous spinal cord stimulator (SCONE, SpineX, Inc.) will deliver non-invasive electrical stimulation during hand therapy 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 as cathodes to stimulate the cervical spinal cord at two vertebral levels. An additional pair of electrodes will be symmetrically positioned over either the iliac crests or shoulders, functioning as anodes. 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 range from 0 to 120 milliamperes (mA), with incremental increases of 5 mA until reaching the level that facilitates voluntary movement. The stimulation amplitude will be fine-tuned for each specific activity based on the therapist's observation.
  • Occupational Therapy — OTHER
    The hand therapy 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. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each training session. Activities are chosen according to the participant's ability, interests, and needs and are modified as function progresses over time.

Study Details

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

Key Dates

Start date
Aug 8, 2024
Status verified
Aug 2024
Primary completion
Jul 1, 2025
Completion
Jul 1, 2025

Study Design

Enrollment
4 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Hand Therapy alone
    Participants randomized to hand therapy alone will participate in therapy sessions three times per week, 60 minutes per session for six weeks.
  • Experimental: Hand Therapy + Stimulation
    Participants will receive non-invasive transcutaneous electrical spinal cord stimulation paired with hand therapy sessions three times per week, 60 minutes per session, for six weeks.

Primary Outcome Measure

Nine-Hole Peg Test [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98133
Sarah Simmons, MD, PhD
[email protected]
Fatma Inanici, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

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

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