Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis

University Health Network, Toronto

Status: Not yet enrolling

Conditions: Balance; Distorted; Multiple Sclerosis; Gait; Mobility Limitation

Treatments: Other: Balance training only; Other: Balance training wiith combined neuromodulation (TSCS+FES); Other: Balance training with FES

Study type: Interventional

Funder types: Other

Identifiers

NCT07174973

1431505

Details and patient eligibility

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

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Balance training only

Sham Comparator group

Description:

Participants in this group complete the standardized balance training program with sham electrical stimulation.

Treatment:

Other: Balance training only

Balance training with FES

Active Comparator group

Description:

This group will receive active FES+ sham TSCS (FES only group) duing balance training

Treatment:

Other: Balance training with FES

Balance training wiith combined neuromodulation (TSCS+FES)

Active Comparator group

Description:

This group will receive both TSCS \& FES (combined neuromodulation) during balance training

Treatment:

Other: Balance training wiith combined neuromodulation (TSCS+FES)