Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis

NCT ID: NCT07174973

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-30
• Study Completion Date: 2028-12-30

Brief 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

Conditions

Multiple Sclerosis; Mobility Limitation; Balance; Distorted; Gait

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Balance training only

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

Group Type: SHAM_COMPARATOR

Balance training only

Intervention Type: OTHER

Participants in this group complete the standardized balance training program without electrical stimulation. Sessions are conducted in a safety harness and consist of interactive, game-based balance exercises performed on a force plate, which provides real-time visual feedback of body sway. Tasks are designed to challenge postural control by requiring weight shifting in multiple directions, maintaining stability during perturbations, and progressively increasing task difficulty.

Balance training with FES

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

Group Type: ACTIVE_COMPARATOR

Balance training with FES

Intervention Type: OTHER

Participants assigned to this group complete a standardized balance training program while receiving FES to the lower limb muscles. Training sessions involve standing in a safety harness and performing interactive, game-based balance tasks on a force plate that provides real-time visual feedback of body sway.

FES will be applied bilaterally to specific leg muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) using surface electrodes. Stimulation parameters (pulse width, frequency, and amplitude) are individually adjusted to produce visible yet comfortable muscle contractions that support functional standing and balance activities. Stimulation is delivered in synchrony with balance exercises to augment muscle activation during postural adjustments.

Balance training wiith combined neuromodulation (TSCS+FES)

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

Group Type: ACTIVE_COMPARATOR

Balance training wiith combined neuromodulation (TSCS+FES)

Intervention Type: OTHER

Participants in this group complete the standardized balance training program while receiving both FES and TSCS. Training sessions take place in a safety harness and involve interactive, game-based balance exercises performed on a force plate with real-time visual feedback of body sway.FES is delivered bilaterally to lower limb muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) through surface electrodes. Stimulation parameters (pulse width, frequency, amplitude) are individualized to produce visible, comfortable contractions that facilitate muscle activation during postural tasks.TSCS is applied simultaneously via electrodes placed over the thoracolumbar spinal region to modulate spinal excitability and enhance neuromuscular control. Standardized stimulation parameters are used across participants, with adjustments made to ensure tolerance and safety.

Interventions

Balance training with FES

Participants assigned to this group complete a standardized balance training program while receiving FES to the lower limb muscles. Training sessions involve standing in a safety harness and performing interactive, game-based balance tasks on a force plate that provides real-time visual feedback of body sway.

FES will be applied bilaterally to specific leg muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) using surface electrodes. Stimulation parameters (pulse width, frequency, and amplitude) are individually adjusted to produce visible yet comfortable muscle contractions that support functional standing and balance activities. Stimulation is delivered in synchrony with balance exercises to augment muscle activation during postural adjustments.

Intervention Type: OTHER

Balance training wiith combined neuromodulation (TSCS+FES)

Participants in this group complete the standardized balance training program while receiving both FES and TSCS. Training sessions take place in a safety harness and involve interactive, game-based balance exercises performed on a force plate with real-time visual feedback of body sway.FES is delivered bilaterally to lower limb muscles (e.g., tibialis anterior, quadriceps, gastrocnemius) through surface electrodes. Stimulation parameters (pulse width, frequency, amplitude) are individualized to produce visible, comfortable contractions that facilitate muscle activation during postural tasks.TSCS is applied simultaneously via electrodes placed over the thoracolumbar spinal region to modulate spinal excitability and enhance neuromuscular control. Standardized stimulation parameters are used across participants, with adjustments made to ensure tolerance and safety.

Intervention Type: OTHER

Balance training only

Participants in this group complete the standardized balance training program without electrical stimulation. Sessions are conducted in a safety harness and consist of interactive, game-based balance exercises performed on a force plate, which provides real-time visual feedback of body sway. Tasks are designed to challenge postural control by requiring weight shifting in multiple directions, maintaining stability during perturbations, and progressively increasing task difficulty.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Direct MS Canada

UNKNOWN

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Kei Masani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Countries

Canada

Facility Contacts

Shirin Dr. Shirin Tajali, PhD

Role: primary

shirin.tajalli@utoronto.ca

416-597-3422 ext. ext. 5301

Other Identifiers

1431505

Identifier Type: -

Identifier Source: org_study_id