Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06552611

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Washington

Seattle, Washington, 98133, United States

Location status: Recruiting

Location contact

Fatma Inanici, MD, PhD

PRINCIPAL_INVESTIGATOR

Sarah Simmons, MD, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Open-loop 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.

Other names: hand therapy, functional task practice

Primary outcomes

  1. Nine-Hole Peg Test

    Time frame: 6 weeks

    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.

  2. NeuroQoL Upper Extremity Function

    Time frame: 6 weeks

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

  3. Participant Drop-out rate

    Time frame: 6 weeks

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

Secondary outcomes

  1. Action Research Arm Test

    Time frame: 6 weeks

    A 19-item clinician-administered observational measure to assess upper extremity performance (coordination, dexterity, and functioning). Items comprising the ARAT are categorized into four subscales (grasp: 6 items, score 0-18; grip: 4 items, score 0-12; pinch: 6 items, score 0-18; and gross movement: 3 items, score 0-9) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Scores are aggregated to a final scale (ranging from 0-57); Higher scores indicate better performance.

  2. Box and Blocks Test

    Time frame: 6 weeks

    Measures unilateral gross manual dexterity. The test kit comprises a wooden box divided into two compartments by a partition and 150 blocks. Participants move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds. Score ranges from 0-150; higher score indicates better function.

  3. Grip force

    Time frame: 6 weeks

    measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-200); higher score indicates better function.

  4. Pinch force

    Time frame: 6 weeks

    measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-100); higher score indicates better function.

  5. Modified Ashworth Scale

    Time frame: 6 weeks

    A clinician-administered test for resistance of a joint to the passive movement. This scale grades the muscle tone from 0 (normal) to 4 (severe spasticity). Higher score indicates worse function

  6. Patient-reported Impact of Spasticity Measure

    Time frame: 6 weeks

    A patient-reported outcome questionnaire assessing the impact of spasticity on function and quality of life over the past week. Score ranges from 0-164; higher scores indicate worse function.

  7. Modified Fatigue Impact Scale

    Time frame: 6 weeks

    A patient-reported outcome questionnaire. It is a modified form of the Fatigue Impact Scale based on items derived from interviews with multiple sclerosis patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue on physical, cognitive, and psychosocial functioning. Score ranges from 0-84; higher score indicates worse function.

  8. PROMIS Pain Interference

    Time frame: 6 weeks

    A patient-reported outcome questionnaire that measures the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Score ranges from 4-20; higher score indicates worse function.

  9. PROMIS Pain Intensity

    Time frame: 6 weeks

    A patient-reported outcome numeric rating scale of pain over the past 7 days. Score ranges from0-10; higher score indicates worse pain

  10. Bowel Control Scale

    Time frame: 6 weeks

    A patient-reported outcome questionnaire for bowel management. This is a subsection of the Multiple Sclerosis Quality of Life Inventory. Score ranges from 0-26; higher score indicates worse function.

  11. Bladder Control Scale

    Time frame: 6 weeks

    A patient-reported outcome questionnaire for bladder management. This is a subsection of the Multiple Sclerosis Quality of Life Inventory. Score ranges from 0-22; higher score indicates worse function.

  12. Global Impression of Change

    Time frame: 6 weeks

    A patient and clinician-reported scale of change pre- to post-intervention, ranging from 1 (indicating "very much improved") to 7 (indicating "very much worse").

  13. Ability to Participate in Social Roles and Activities

    Time frame: 6 weeks

    A self-report of health-related quality of life in 17 domains and sub-domains for adults with neurological disorders. Score ranges from 4-40; higher scores indicates better function.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Simmons, MD, PhD

CONTACT

[email protected]

206-356-6352

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.