Multiple Sclerosis
Conditions
Keywords
spinal cord stimulation, neuromodulation
Brief summary
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)
Interventions
COMBINATION_PRODUCTSpinal Cord Stimulation + Hand/arm Exercises
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.
Sponsors
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of multiple sclerosis 2. Adult individuals between 18 and 70 years of age. 3. Impaired upper extremity function as evidenced by 9-Hole Peg Test \>33.5 sec 4. Partner or caregiver willing to provide support during intervention 5. Ability to give consent 6. 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. They must also be willing to practice adequate contraception (which may include implant, intrauterine device (IUD), injection, pill, patch, vaginal ring, or diaphragm) during the study period.
Exclusion criteria
1. Multiple sclerosis relapse within the past 3 months (given that natural recovery from MS relapse could skew results) 2. History of seizure, active implanted stimulator (pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump 3. Upper extremity Botox injection within the past 4 months 4. 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.), 5. History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia. 6. Contraindication to transcranial magnetic stimulation 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. Pregnancy and breastfeeding (Childbearing potential will be asked at screening, baseline, and every subsequent visit in which the subject would receive transcutaneous spinal cord stimulation whether they could be pregnant. Pregnancy will be ruled out by home over-the-counter urine pregnancy tests for all females of childbearing potential (1) at the time of enrollment and (2) at the beginning of intervention arms. Additional pregnancy tests may be performed if there is concern about pregnancy.) 11. Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention rate | 8 weeks | Percentage of participants who complete the intervention protocol. (0-100%) |
| Acceptability of intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 9-hole PEG Test | 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. |
| Action Reach Arm Test | 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. |
| Box & Blocks Test | 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 |
| Modified Ashworth Scale | 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). |
| • NeuroQoL Upper Extremity Function | 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 |
| Pinch & Grip Force | 8 weeks | measurement of hand strengths using dynamometry. Measured in pounds (score ranges from 0-100); higher score indicates better function. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Simmons, MD, PhD
University of Washington
Outcome results
None listed