Clinical trial NCT06552611: Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
Official title: Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Rehabilitation
Neuromodulation
Spinal Cord stimulation
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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. 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


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of MS
2. Age between 21 and 70
3. Presence of upper extremity functional impairment (correlating with raw score ≤34 on NeuroQOL Upper Extremity Function short-form questionnaire),
4. Ability to attend intervention and assessment sessions 3 times per week.
5. 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:

1. Relapse within the past 6 months (given that natural recovery from relapse could skew results)
2. Active implanted stimulator or baclofen pump
3. Upper extremity botox injection within the past 6 months
4. Unstable dalfampridine usage during study duration (which may interfere with functional outcomes)
5. 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.)
6. History of major active psychiatric illness that could interfere with treatment, such as severe depression, alcohol/drug abuse, or dementia
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. Pregnant and/or breastfeeding
11. Lack of ability to fully comprehend, cooperate, and/or safely perform study procedures in the investigator's opinion/judgment
12. Inability to give consent

Primary outcomes:
measure: Nine-Hole Peg Test
timeFrame: 6 weeks
measure: NeuroQoL Upper Extremity Function
timeFrame: 6 weeks
measure: Participant Drop-out rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Action Research Arm Test
timeFrame: 6 weeks
measure: Box and Blocks Test
timeFrame: 6 weeks
measure: Grip force
timeFrame: 6 weeks
measure: Pinch force
timeFrame: 6 weeks
measure: Modified Ashworth Scale
timeFrame: 6 weeks
measure: Patient-reported Impact of Spasticity Measure
timeFrame: 6 weeks
measure: Modified Fatigue Impact Scale
timeFrame: 6 weeks
measure: PROMIS Pain Interference
timeFrame: 6 weeks
measure: PROMIS Pain Intensity
timeFrame: 6 weeks
measure: Bowel Control Scale
timeFrame: 6 weeks
measure: Bladder Control Scale
timeFrame: 6 weeks
measure: Global Impression of Change
timeFrame: 6 weeks
measure: Ability to Participate in Social Roles and Activities
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Sarah Simmons, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: