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

NCT06552611 | Recruiting Phase 1 DMC

• 1 other identifier: STUDY00020787
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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. 1.transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants
2. 2.transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone
3. 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

Keywords

Rehabilitation; Neuromodulation; Spinal Cord stimulation

Outcome Measures

Primary Outcomes (3)

• Nine-Hole Peg Test

  Nine-Hole Peg Test is a standardized, quantitative assessment used to measure finger dexterity. Score is time it takes to complete task (range 15-180 seconds). Higher score = worse outcome.

  6 weeks

• NeuroQoL Upper Extremity Function

  A self-report of health-related quality of life for adults with neurological disorders. Score ranges from 8-40; higher score = better function

  6 weeks

• Participant Drop-out rate

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

  6 weeks

Secondary Outcomes (13)

• Action Research Arm Test

  6 weeks

• Box and Blocks Test

  6 weeks

• Grip force

  6 weeks

• Pinch force

  6 weeks

• Modified Ashworth Scale

  6 weeks

Study Arms (2)

Hand Therapy alone

ACTIVE COMPARATOR

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

Other: Occupational Therapy

Hand Therapy + Stimulation

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.

Combination Product: Transcutaneous electrical spinal cord stimulation + therapy; Other: Occupational Therapy

Interventions

Transcutaneous electrical spinal cord stimulation + therapy COMBINATION_PRODUCT

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.

Also known as: Open-loop stimulation

Hand Therapy + Stimulation

Occupational Therapy OTHER

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.

Also known as: hand therapy, functional task practice

Hand Therapy + Stimulation; Hand Therapy alone

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)
• 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
• 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
• Pregnant and/or breastfeeding
• Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment
• Inability to give consent

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98133, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Therapeutics; Occupational Therapy

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)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Sarah Simmons, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Simmons, MD, PhD

CONTACT

206-356-6352; sbs2@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Rehabilitation Medicine

Model Details: This is a prospective, open-label, two-intervention arm cross-over clinical trial of transcutaneous spinal cord stimulation combined with therapy compared to therapy alone in four adults with MS and upper extremity impairment.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 14, 2024
• Study Start: August 8, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

US (1)