Non-invasive Electrical Spinal Cord Stimulation To Restore Upper Extremity Function in Multiple Sclerosis

Обзор

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

Вмешательства

• Комбинированный продукт Transcutaneous electrical spinal cord stimulation + therapy
  A two-channel transcutaneous spinal cord stimulator (SCONE, SpineX, Inc.) will deliver non-invasive electrical stimulation during hand therapy 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 as cathodes to stimulate the cervical spinal cord at two vertebral levels. An additional pair of electrodes will be symmetrically positioned over either the iliac crests or shoulders, functioning as
• Другое Occupational Therapy
  The hand therapy 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. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each training session. Activities are ch

Первичные конечные точки

• Nine-Hole Peg Test [Срок оценки: 6 weeks]
• NeuroQoL Upper Extremity Function [Срок оценки: 6 weeks]
• Participant Drop-out rate [Срок оценки: 6 weeks]

Вторичные конечные точки (12)

• Action Research Arm Test [Срок оценки: 6 weeks]
• Box and Blocks Test [Срок оценки: 6 weeks]
• Grip force [Срок оценки: 6 weeks]
• Pinch force [Срок оценки: 6 weeks]
• Modified Ashworth Scale [Срок оценки: 6 weeks]
• Patient-reported Impact of Spasticity Measure [Срок оценки: 6 weeks]
• Modified Fatigue Impact Scale [Срок оценки: 6 weeks]
• PROMIS Pain Interference [Срок оценки: 6 weeks]
• PROMIS Pain Intensity [Срок оценки: 6 weeks]
• Bowel Control Scale [Срок оценки: 6 weeks]
• Bladder Control Scale [Срок оценки: 6 weeks]
• Global Impression of Change [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Washington — Seattle

Идентификаторы

NCT: NCT06552611 · STUDY00020787

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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