Recruiting

Electrical Spinal Cord Stimulation for Upper Extremity Function in Multiple Sclerosis

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What is being tested

Transcutaneous electrical spinal cord stimulation + therapy

+ Occupational Therapy

Combination ProductOther
Who is being recruted

Autoimmune Diseases+4

+ Demyelinating Diseases

+ Immune System Diseases

From 21 to 70 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorUniversity of Washington
Study ContactSarah Simmons, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 8, 2024

Actual date on which the first participant was enrolled.

This study focuses on exploring a new treatment method for adults with multiple sclerosis (MS), specifically targeting those with difficulties in using their arms and hands. Traditional treatments for MS aim to stop new lesions from forming in the nervous system, but they don't help repair existing damage. This study is important because it looks at a potential new way to restore function and improve quality of life by combining electrical spinal cord stimulation with occupational therapy. This approach could lead to better outcomes in terms of hand and arm function, as well as potentially easing symptoms like pain and muscle stiffness. Participants in the study will undergo two different treatment phases, each lasting six weeks. One phase involves receiving spinal cord stimulation through electrodes placed on the skin, along with occupational therapy. The other phase consists of occupational therapy alone. The order of these treatments will be random, and a six-week break is included between them to clear any effects from the first phase. Researchers will assess if the stimulation is safe and if it effectively improves arm function and symptoms related to quality of life, such as pain and spasticity. The study aims to establish whether adding spinal cord stimulation to therapy offers more benefits than therapy by itself.

Official TitleNon-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
NCT06552611
Principal SponsorUniversity of Washington
Study ContactSarah Simmons, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

4 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNS

Criteria

5 inclusion criteria required to participate
Diagnosis of MS

Age between 21 and 70

Presence of upper extremity functional impairment (correlating with raw score ≤34 on NeuroQOL Upper Extremity Function short-form questionnaire),

Ability to attend intervention and assessment sessions 3 times per week.

Show More Criteria

12 exclusion criteria prevent from participating
Relapse within the past 6 months (given that natural recovery from relapse could skew results)

Active implanted stimulator or baclofen pump

Upper extremity botox injection within the past 6 months

Unstable dalfampridine usage during study duration (which may interfere with functional outcomes)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
Participants randomized to hand therapy alone will participate in therapy sessions three times per week, 60 minutes per session for six weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University of Washington

Seattle, United StatesOpen University of Washington in Google Maps
Recruiting
One Study Center