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

NCT07673354 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2026-06-29

No results posted yet for this study

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. 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)

Conditions

Interventions

COMBINATION_PRODUCT

Spinal Cord Stimulation + Hand/arm Exercises

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.

Sponsors & Collaborators

Principal Investigators

  • Sarah Simmons, MD, PhD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-16
Primary Completion
2027-03-01
Completion
2027-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07673354 on ClinicalTrials.gov