University of Washington
Seattle, Washington, 98195, United States
NCT Number: NCT07673354
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)
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Seattle, Washington, 98195, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 8 weeks
Percentage of participants who complete the intervention protocol. (0-100%)
Time frame: 8 weeks
a questionnaire with 7 multiple choice questions on a 5-point Likert scale, and one open-ended comment section designed to assess participant's acceptability and tolerability of transcutaneous spinal cord stimulation.
Time frame: 8 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.
Time frame: 8 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. Higher scores indicate better performance.
Time frame: 8 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
Time frame: 8 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).
Time frame: 8 weeks
A self-report of health-related quality of life for adults with neurological disorders. Score ranges from 8-40; higher score = better function
Time frame: 8 weeks
measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-100); higher score indicates better function.
University of Washington
Other
Transcutaneous Spinal Cord Stimulation for Recovery of Hand and Arm Function in Multiple Sclerosis: A Home-Based Study
Acronym: eSTIM-MS Home
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