A pilot randomized controlled trial of neuromodulation-augmented balance training in people with multiple sclerosis: STIM-Balance Protocol.
Shirin Tajali, Jillian Scandiffio, Yasma Ali-Hassan...
https://pubmed.ncbi.nlm.nih.gov/41990010Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07174973
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
Led by University Health Network, Toronto · Updated on 2026-03-16
24
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
D
Direct MS Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how combining balance training with two types of electrical stimulation can help people with Multiple Sclerosis (MS) improve leg strength, coordination, and balance. MS often leads to difficulty walking and an increased risk of falls, reducing independence. This study compares three approaches: balance training alone, balance training with Functional Electrical Stimulation (FES), and balance training with both FES and Transcutaneous Spinal Cord Stimulation (TSCS). The study is funded by MS Canada and aims to understand how these methods affect motor control and balance in MS patients. Participants will be randomly assigned to one of three groups. One group will do balance training with sham electrical stimulation, the second will have balance training combined with active FES to leg muscles, and the third group will receive balance training with both FES and TSCS, which stimulates the spinal cord through the skin. All groups will complete 12 supervised sessions over six weeks involving interactive balance games while standing in a safety harness, using a force plate that gives real-time visual feedback to challenge and improve postural control. Participants will be assessed at three times: before starting training, after completing the six weeks of training, and eight weeks after training ends. Assessments include clinical mobility and balance tests like the Timed Up and Go and Berg Balance Scale, computerized balance tests, questionnaires about walking and balance confidence, and neurophysiological measures of brain-spinal cord-muscle communication. Safety and feasibility will be monitored throughout the study. The total participation duration spans about 14 weeks from baseline to follow-up.
CONDITIONS
Brief Title
Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of Multiple Sclerosis according to the revised McDonald criteria
- Age 18 to 65 years
- Ability to walk at least 100 meters, with or without an assistive device, without resting
- Self-reported impaired balance during standing or walking in daily activities
You will not qualify if you...
- Uncorrected visual problems
- Cognitive impairment affecting understanding or completion of study tasks
- Ongoing MS exacerbation or paroxysmal vertigo
- Other neurological or orthopedic conditions affecting balance
- Recent rehabilitation therapies within one month before recruitment
- Planned or recent botulinum toxin injections to the legs during the study
- Peripheral nerve damage in the legs
- Contraindications to electrical stimulation including implanted electronic devices, recent cancer treatment, uncontrolled epilepsy, skin issues at electrode sites, pregnancy, or active deep vein thrombosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 weeks
Participants complete a standardized balance training program with different types of stimulation depending on their group assignment, including balance training only, balance training with functional electrical stimulation (FES), or balance training with combined transcutaneous spinal cord stimulation (TSCS) and FES. Training sessions involve standing in a safety harness and performing interactive, game-based balance exercises with real-time visual feedback.
12 training sessions over 6 weeks
Follow-up
Duration - 8 weeks post-intervention
Participants are monitored after completing the training program to assess balance, walking ability, neurophysiological function, and safety outcomes.
1 follow-up visit approximately 8 weeks after treatment completion
Trial Site Locations
Total: 1 location
1
Toronto Rehabilitation Institute-Lyndhurst Center
Toronto, Ontario, Canada, m4g3v9
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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