Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis

Официальное название

Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis: Evaluating the Combined Effects of Transcutaneous Spinal Cord Stimulation, Functional Electrical Stimulation, and Visual Feedback Balance Training

Обзор

This study will evaluate the effects of combining balance training with electrical stimulation techniques in individuals with Multiple Sclerosis (MS). MS commonly impairs leg strength, coordination, and balance, increasing the risk of falls and reducing independence. The interventions include:Balance training only, Balance training with Functional Electrical Stimulation (FES), and Balance training with FES and Transcutaneous Spinal Cord Stimulation (TSCS). FES delivers small electrical pulses to leg muscles, while TSCS delivers electrical signals through the skin to stimulate the spinal cord and enhance motor control. The study will enroll up to 24 participants over a 3-year period. This trial is funded by MS Canada. Participants will be randomly assigned to one of three groups: (1) balance training only, (2) balance training with FES, or (3) balance training with FES and TSCS. All participants will complete 12 supervised training sessions over 6 weeks. During each session, participants will engage in interactive balance games while standing in a safety harness.Outcome assessments will be conducted at three time points: baseline (prior to training), post-intervention (after 6 weeks), and follow-up (8 weeks after training). Assessments will include: * Clinical tests of mobility and balance (Timed Up and Go:TUG, 10-Meter Walk Test:10MWT, Berg Balance Scale:BBS) * Computerized balance testing using a force plate * Questionnaires on walking ability, fear of falling, and balance confidence * Neurophysiological measures of brain-spinal cord-muscle communication before and after training

Вмешательства

• Другое Balance training with FES
  Participants assigned to this group complete a standardized balance training program while receiving FES to the lower limb muscles. Training sessions involve standing in a safety harness and performing interactive, game-based balance tasks on a force plate that provides real-time visual feedback of body sway. FES will be applied bilaterally to specific leg muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) using surface electrodes. Stimulation parameters (pulse width, frequency, and a
• Другое Balance training wiith combined neuromodulation (TSCS+FES)
  Participants in this group complete the standardized balance training program while receiving both FES and TSCS. Training sessions take place in a safety harness and involve interactive, game-based balance exercises performed on a force plate with real-time visual feedback of body sway.FES is delivered bilaterally to lower limb muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) through surface electrodes. Stimulation parameters (pulse width, frequency, amplitude) are individualized to
• Другое Balance training only
  Participants in this group complete the standardized balance training program without electrical stimulation. Sessions are conducted in a safety harness and consist of interactive, game-based balance exercises performed on a force plate, which provides real-time visual feedback of body sway. Tasks are designed to challenge postural control by requiring weight shifting in multiple directions, maintaining stability during perturbations, and progressively increasing task difficulty.

Первичные конечные точки

• Timed Up and Go (TUG) [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]
• Timed 25 feet walk test (T25FWT) [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]
• Berg Balance Scale (BBS): [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]
• Static & Dynamic balance tests [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]
• MS Walking Scale-12 (MSWS-12) [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]
• Falls Efficacy Scale-International (FES-I) [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]
• Activities-Specific Balance Confidence (ABC) Scale [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]
• Acceptability Outcomes [Срок оценки: -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions)]
• Feasibility and Safety Outcomes [Срок оценки: - All adverse events will bereported throughout the study period - Feasibility metrics at Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) and Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]

Вторичные конечные точки (2)

• Neurophysiological assessment:corticospinal excitability [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]
• Neurophysiological Measures :Spinal excitability (SMEPs) [Срок оценки: -Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)]

Критерии участия

Participants will be eligible if they meet the following conditions:

• Confirmed diagnosis of Multiple Sclerosis (MS) according to the revised McDonald criteria
• Age ≤ 65 years
• Ability to walk at least 100 meters, with or without an assistive device, and without requiring rest
• Self-reported perception of impaired balance during standing or walking in daily activities

Критерии исключения

• Participants will be excluded if they present with any of the following:
• Uncorrected visual problems
• Cognitive impairment affecting comprehension of instructions or completion of self-administered outcome measures
• Ongoing MS exacerbation or paroxysmal vertigo
• Concurrent neurological or orthopedic conditions affecting balance
• Recent participation in rehabilitation therapies (physical therapy, occupational therapy, or vestibular therapy) within one month prior to recruitment
• Planned or recent injection of botulinum toxin to the legs during the intervention period
• Peripheral nerve damage affecting the legs
• Contraindications to electrical stimulation, including:implanted electronic device, active cancer or radiation treatment within the past 6 months, uncontrolled epilepsy, skin rash or open wound at electrode site, pregnancy, active deep vein thrombosis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Toronto Rehabilitation Institute-Lyndhurst Center — Toronto

Публикации

• Tajali S, Scandiffio J, Ali-Hassan Y, Lim D, Ghosh R, Atputharaj S, Musselman K, Simpson R, Masani K. A pilot randomized controlled trial of neuromodulation-augmented balance training in people with multiple sclerosis: STIM-Balance Protocol. PLoS One. 2026 Apr 16;21(4):e0346491. doi: 10.1371/journal.pone.0346491. eCollection 2026. PMID 41990010

Идентификаторы

NCT: NCT07174973 · 1431505

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗