Innovative Approaches to Enhance Balance and Neuroplasticity in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Health Network, Toronto
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Balance training with FES
Other interventionParticipants 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)
Other interventionParticipants 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.
Balance training only
Other interventionParticipants 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.
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Balance training onlySham comparator 1 intervention
Group B: Balance training with FESActive comparator 1 intervention
Group C: Balance training wiith combined neuromodulation (TSCS+FES)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Timed Up and Go (TUG)
Participants begin seated in a standard chair with their back against the chairrest and arms on the armrests. On the command "go," they stand up, walk 3 meters at a comfortable and safe pace, turn around, return to the chair, and sit down. The time to complete the task is recorded in seconds, with shorter times indicating better mobility. For the dual-task cognitive TUG, participants perform the same procedure while simultaneously completing a cognitive task (counting backward by threes). The score is the time in seconds to complete the task, with shorter times indicating better mobility.
Time frame
-Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)2
Timed 25 feet walk test (T25FWT)
The Timed 25-Foot Walk Test (T25FWT) is a standardized clinical measure of walking speed. Participants are instructed to walk a distance of 25 feet at their usual comfortable pace. Timing is recorded over the middle 6 meters to minimize the effects of acceleration and deceleration, with 2-meter lead-in and 2-meter lead-out zones. The test is performed twice, and the average walking speed (m/s) is calculated, with higher speeds indicating better mobility.
Time frame
-Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)3
Berg Balance Scale (BBS):
BBS is a 14-item clinical assessment of static and dynamic balance. Each item evaluates performance on a functional task such as standing unsupported, reaching forward, turning, or standing on one leg. Tasks are scored on a 5-point ordinal scale ranging from 0 (unable to perform) to 4 (independent performance), with a maximum total score of 56. Higher scores indicate better balance
Time frame
-Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)4
Static & Dynamic balance tests
For the static balance test, participants will stand for 100 seconds on a force plate under two conditions: (1) eyes open and (2) eyes closed. For the dynamic balance test, participants will stand on the force plate and lean as far as possible in the forward, backward, and sideways directions. During these tasks, body sway, postural movements will be recorded. Visual feedback of calculated body sway will be displayed on a monitor, and participants will be instructed to shift their body toward the indicated directions.
Time frame
-Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)Secondary outcomes
1
Neurophysiological assessment:corticospinal excitability
The strength of the connection between the brain and muscles will be measured using TMS. During this test, the participant sits comfortably in a chair while a small device placed over the head delivers brief magnetic pulses. These pulses activate specific brain areas and the responses in the muscles are recorded, providing information about brain-muscle communication.The MEP (motor evoked potential) score is the amplitude of the muscle response in microvolts (µV or mV), with larger amplitudes indicating stronger corticospinal excitability and smaller or absent responses reflecting weaker or impaired brain-muscle connectivity.
Time frame
-Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)2
Neurophysiological Measures :Spinal excitability (SMEPs)
Spinal motor evoked potentials (SMEPs) will be assessed with double-pulse stimulation (Digitimer, Model DS7A, Welwyn Garden City, UK) delivered over L1-L2 (two monophasic pulses with 1ms pulse width and a 50 ms inter-stimulus interval). Surface EMG will be recorded from the more affected side or dominant side in case of symmetrical involvement from four lower-limb muscles: soleus, tibialis anterior, rectus femoris, and biceps femoris. The same amplifier will be used to both amplify and band-pass-filter the data, as described above. Recruitment curves will be generated by increasing stimulation intensity from 5 mA to the participant's maximal tolerable level in 5-mA increments. At each intensity, five paired-pulse stimulations were delivered with 5-second inter-trial intervals.
Time frame
-Baseline (Week 0, prior to intervention start) -Post-intervention (Week 6, within 1 week after completion of the 12 training sessions) - Follow-up (Week 8 post-intervention, approximately Week 14 from baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Direct MS Canada
Collaborator
Source ClinicalTrials.gov