Multiple Sclerosis (MS) Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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⁃ 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

Locations
Other Locations
Canada
Toronto Rehabilitation Institute-Lyndhurst Center
RECRUITING
Toronto
Time Frame
Start Date: 2025-12-30
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 24
Treatments
Sham_comparator: Balance training only
Participants in this group complete the standardized balance training program with sham electrical stimulation.
Active_comparator: Balance training with FES
This group will receive active FES+ sham TSCS (FES only group) duing balance training
Active_comparator: Balance training wiith combined neuromodulation (TSCS+FES)
This group will receive both TSCS \& FES (combined neuromodulation) during balance training
Related Therapeutic Areas
Sponsors
Collaborators: Direct MS Canada
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov