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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Exercise + Spinal Cord Stimulation | Experimental | The 8-week intervention will consist of approximately 1-hour sessions, 3-4x times per week. These sessions will occur in the participant's home, during which hand/arm exercises and transcutaneous spinal cord stimulation (tSCS) will be performed. A caregiver or partner will assist with electrode placement and tSCS administration. Exercises are similar to what would be prescribed by an occupational therapist for an outpatient home exercise program, and include: repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation + Hand/arm Exercises | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention rate | Percentage of participants who complete the intervention protocol. (0-100%) | 8 weeks |
| Acceptability of intervention | 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 9-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. | 8 weeks |
| Action Reach Arm Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Simmons, MD, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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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.
| 8 weeks |
| Box & Blocks Test | 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 | 8 weeks |
| Modified Ashworth Scale | 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). | 8 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 | 8 weeks |
| Pinch & Grip Force | measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-100); higher score indicates better function. | 8 weeks |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |