Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis

Recruiting · NCT07174973 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto

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Multiple Sclerosis

Interventions studied

Balance training onlyBalance training wiith combined neuromodulation (TSCS+FES)Balance training with FES

What this trial is about

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

Who can take part

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

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 Exclusion Criteria: * 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

Where it is running

1 location listed.

Toronto Rehabilitation Institute-Lyndhurst Center - Toronto, Ontario, Canada

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →