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

NCT07673354 | Enrolling By Invitation DMC

• 1 other identifier: STUDY00024536
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will be feasible and acceptable by participants
2. 2.in-home transcutaneous spinal cord stimulation combined with hand/arm exercises will lead to improvements in upper extremity function after 8-weeks
3. 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)

Conditions

Multiple Sclerosis

Keywords

spinal cord stimulation; neuromodulation

Outcome Measures

Primary Outcomes (2)

• Retention rate

  Percentage of participants who complete the intervention protocol. (0-100%)

  8 weeks

• Acceptability of intervention

  a questionnaire with 7 multiple choice questions on a 5-point Likert scale, and one open-ended comment section designed to assess participant's acceptability and tolerability of transcutaneous spinal cord stimulation.

  8 weeks

Secondary Outcomes (6)

• 9-hole PEG Test

  8 weeks

• Action Reach Arm Test

  8 weeks

• Box & Blocks Test

  8 weeks

• Modified Ashworth Scale

  8 weeks

• • NeuroQoL Upper Extremity Function

  8 weeks

Study Arms (1)

Home Exercise + Spinal Cord Stimulation

EXPERIMENTAL

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.

Combination Product: Spinal Cord Stimulation + Hand/arm Exercises

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.

Home Exercise + Spinal Cord Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of multiple sclerosis
• Adult individuals between 18 and 70 years of age.
• Impaired upper extremity function as evidenced by 9-Hole Peg Test \>33.5 sec
• Partner or caregiver willing to provide support during intervention
• Ability to give consent
• 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. They must also be willing to practice adequate contraception (which may include implant, intrauterine device (IUD), injection, pill, patch, vaginal ring, or diaphragm) during the study period.

You may not qualify if:

• Multiple sclerosis relapse within the past 3 months (given that natural recovery from MS relapse could skew results)
• History of seizure, active implanted stimulator (pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
• Upper extremity Botox injection within the past 4 months
• 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.),
• History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia.
• Contraindication to transcranial magnetic stimulation
• 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,
• Presence of severe joint contractures in the affected hand and arm that may interfere with study activities or outcome measures,
• Severe spasticity, as defined by an Ashworth score of 4 in both sides of the upper limb
• Pregnancy and breastfeeding (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation whether they could be pregnant. Pregnancy will be ruled out by home over-the-counter urine pregnancy tests for all females of childbearing potential (1) at the time of enrollment and (2) at the beginning of intervention arms. Additional pregnancy tests may be performed if there is concern about pregnancy.)
• Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Sarah Simmons, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)