Enhancing balance in multiple sclerosis with training plus electrical stimulation
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
This trial will test whether adding leg muscle stimulation and/or noninvasive spinal stimulation to balance training helps adults with multiple sclerosis who have balance or walking trouble.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07174973 on ClinicalTrials.gov |
What this trial studies
This randomized, single-center interventional study will enroll up to 24 adults with MS and self-reported balance impairment and assign them to one of three groups: balance training only; balance training with functional electrical stimulation (FES); or balance training with FES plus transcutaneous spinal cord stimulation (TSCS). Participants complete 12 supervised training sessions over six weeks. FES delivers small pulses to leg muscles and TSCS delivers surface stimulation to modulate spinal circuits, and standardized protocols will be used across groups. Primary outcomes will examine balance, gait, mobility and safety to determine whether neuromodulation adds benefit beyond training alone.
Who should consider this trial
Good fit: Adults with a confirmed MS diagnosis who are 65 or younger, can walk at least 100 meters (with or without a device), and report balance problems in daily life are ideal candidates.
Not a fit: People with uncorrected vision problems, significant cognitive impairment, recent MS exacerbation, other neurological or orthopedic conditions affecting balance, or who cannot walk 100 meters are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could improve standing and walking balance, reduce fall risk, and increase daily independence for people with MS.
How similar studies have performed: Functional electrical stimulation has shown benefit for gait in prior MS studies, spinal stimulation is an emerging approach with preliminary promise, and combining these modalities with balance training is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- Toronto Rehabilitation Institute-Lyndhurst Center — Toronto, Ontario, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.