Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Participant Drop-out rate
研究概览
简要总结
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:
- transcutaneous spinal cord stimulation combined with therapy will be feasible and acceptable by participants
- transcutaneous spinal cord stimulation combined with therapy will lead to improvements in upper extremity function compared to occupational therapy alone
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Hand Therapy alone
Participants randomized to hand therapy alone will participate in therapy sessions three times per week, 60 minutes per session for six weeks.
干预措施: Occupational Therapy (Other)
Hand Therapy + Stimulation
Participants will receive non-invasive transcutaneous electrical spinal cord stimulation paired with hand therapy sessions three times per week, 60 minutes per session, for six weeks.
干预措施: Transcutaneous electrical spinal cord stimulation + therapy (Combination Product)
Hand Therapy + Stimulation
Participants will receive non-invasive transcutaneous electrical spinal cord stimulation paired with hand therapy sessions three times per week, 60 minutes per session, for six weeks.
干预措施: Occupational Therapy (Other)
结局指标
主要结局
Participant Drop-out rate
时间窗: 6 weeks
Percentage of participants who complete the intervention protocol. (0-100%)
Nine-Hole Peg Test
时间窗: 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.
NeuroQoL Upper Extremity Function
时间窗: 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
次要结局
- Global Impression of Change(6 weeks)
- Modified Ashworth Scale(6 weeks)
- Ability to Participate in Social Roles and Activities(6 weeks)
- Bladder Control Scale(6 weeks)
- Action Research Arm Test(6 weeks)
- Pinch force(6 weeks)
- PROMIS Pain Intensity(6 weeks)
- Bowel Control Scale(6 weeks)
- Patient-reported Impact of Spasticity Measure(6 weeks)
- Modified Fatigue Impact Scale(6 weeks)
- Box and Blocks Test(6 weeks)
- Grip force(6 weeks)
- PROMIS Pain Interference(6 weeks)
研究者
Sarah Simmons, MD, PhD
Assistant Professor, Department of Rehabilitation Medicine
University of Washington