Recruiting
Phase 1

Electrical Spinal Cord Stimulation

Sponsor:

University of Washington

Code:

NCT06552611

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

Interventions

Transcutaneous electrical spinal cord stimulation + therapy

Occupational Therapy

Study Details

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) 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

Conditions

Multiple Sclerosis

Study ID

NCT06552611

Start date

Aug 8, 2024

Status verified date

Aug, 2024

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Transcutaneous electrical spinal cord stimulation + therapy

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

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.

Primary outcome measure

  • Nine-Hole Peg Test [ Time Frame: 6 weeks ]
  • NeuroQoL Upper Extremity Function [ Time Frame: 6 weeks ]
  • Participant Drop-out rate [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Sarah Simmons, MD, PhD

206-356-6352sbs2@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98133

Contacts

Sarah Simmons, MD, PhD

sbs2@uw.edu

Principal Investigator:

Fatma Inanici, MD, PhD

More Information

Sponsor

University of Washington

Last update posted

Aug 14, 2024

Last verified

Aug, 2024

Keywords

  • Rehabilitation
  • Neuromodulation
  • Spinal Cord stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-08-14.