RECRUITING

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

Conditions

Multiple Sclerosis Rehabilitation Neuromodulation Spinal Cord stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-08

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06552611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Sarah Simmons, MD, PhD

CONTACT

206-356-6352

sbs2@uw.edu

Principal Investigator

Sarah Simmons, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

University of Washington

Seattle, Washington, 98133

United States

Collaborators and Investigators

Sponsor: University of Washington

Sarah Simmons, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2024-08-08

Study Completion Date2025-07-01

Terms related to this study

Keywords Provided by Researchers

Rehabilitation
Neuromodulation
Spinal Cord stimulation

Additional Relevant MeSH Terms

Multiple Sclerosis