Spinal Cord InjuriesNCT05940636
A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity
A study testing Activity-based rehabilitation+electrical stimulation in people with Spinal Cord Injuries and Muscle Pareses, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Many people with partial damages in their spinal cord (iSCI) have physical impairments such as muscle paralysis in legs which make standing balance difficult. Poor balance control often leads to falls, injuries, and hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Muscle Pareses, Fall
- What is being tested?
- Activity-based rehabilitation+electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 5 Nov 2023to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A traumatic or non-traumatic, non-progressive motor iSCI [American Spinal Injury Association Impairment Scale (AIS) rating of C or D];
- More than 1-year post-injury;
- ≥18 years old;
- BBS score <46;
- Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke)
Who cannot join
- Neurological lesion levels below T12 ;
- Severe spasticity in the legs;
- Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee;
- Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation);
- A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied;
- Pregnancy;
- History of epilepsy;
- Contraindications for electrical stimulation (i.e. implanted electronic device, active cancer or radiation in past months, epilepsy, skin rash/wound at a potential electrode site)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute-Lyndhurst Center
Toronto, Ontario, m4g3v9
About this study
Official title: A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity After Incomplete SCI
Many people with partial damages in their spinal cord (iSCI) have physical impairments such as muscle paralysis in legs which make standing balance difficult. Poor balance control often leads to falls, injuries, and hospitalization. Therefore, improvement of standing balance is an important therapeutic goal for these individuals. Our team has shown that a therapy called visual feedback training (VFT) can improve standing balance by allowing individuals with iSCI to actively participate and follow visual feedback of their body sway on a screen like a computer game. We have also found that the application of low-energy electrical pulses to weak muscles called functional electrical stimulation (FES) during VFT can enhance the training effects. Recently, transcutaneous spinal cord stimulation (TSCS) has been discussed as a promising technique to further promote the rehabilitation effects after SCI by enhancing the connectivity between the brain and spinal cord and within the spinal pathways. However, to date, the potential of combining the two techniques (TSCS+FES) to improve the standing balance remains unknown. In this study, through the completion of a clinical trial, we will investigate the effects of an intervention that combines lumbar TSCS with FES of ankle muscles during VFT on the functional and neurophysiological outcomes in individuals living with iSCI. Participants will be randomly allocated to receive combined TSCS with FES or FES alone during VFT for 12 training sessions over 4 weeks. We expect that the new therapy would further improve balance and strengthen the neural connections between the brain and muscles. The expected changes in the neural connections will be measured by recording electrical signals from the lower limb muscles following stimulation of the motor region of the brain. Results of this study will be used for a larger-scale study in people with iSCI to improve balance and reduce falls during their daily life activities.
Read the detailed description
This is a single-center, randomized controlled trial to test the effects of a novel neuromodulation program on balance performance and neuroplasticity in individuals with iSCI. Participants will be randomly assigned to 2 equal groups labeled as (1) FES with VFT, and (2) combined neuromodulation with VFT. They will complete 8 training sessions over 4 weeks (2 sessions/week). For the FES with VFT group, participants will receive visual feedback regarding their center of pressure location during four games with varying levels of difficulty and FES will be applied bilaterally to SOL and TA via a closed-loop system. Each exercise will be completed 3 times per training session. For the combined neuromodulation with VFT group, the sub-motor threshold, open-loop TSCS will be coupled with closed-loop FES of ankle muscles during VFT. For this purpose, 2 electrical stimulators, one for each leg will stimulate SOL and TA muscles bilaterally while open-loop tonic lumbar TSCS will be applied at an intensity producing paresthesia in most of the lower-limb dermatomes. The range of FES stimulation intensity will vary between the minimal contraction threshold and 80% of the maximal tolerable threshold for each participant during games depending on the instant location of the participant's center of pressure and the location of the desired target during the game. All dependent variables will be assessed prior, immediately after, and 6-weeks after the end of intervention.
- Conditions
- Spinal Cord Injuries, Muscle Pareses, Fall
- Being tested
- Activity-based rehabilitation+electrical stimulation
- Medical subject headings
- Spinal Cord Injuries, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity-based rehabilitation+electrical stimulationOther
Balance training will occur three times per week for four weeks, totaling 12 two-hour sessions. In both groups, you will be asked to stand on a force plate while playing visual feedback training (VFT) games as part of the standing balance training. A force plate is similar to a bathroom scale that you can stand on which measures your body sway during movement. Visual feedback training (VFT) is a type of activity that includes weight-shifting movements in the upright stance. VFT will be done in both groups. There will be different games as shown in figure 1 and the order of the games will be randomly chosen in each session. During each game, there will be targets that will be presented on the screen and you will have to navigate toward them . You will be able to rest between games as needed.
| Study group | Role | What they receive |
|---|---|---|
| FES+TSCS (combined) neuromodulation group | Experimental | For the combined neuromodulation with VFT group, the sub-motor threshold, open-loop TSCS will be coupled with closed-loop FES of ankle muscles during VFT. For this purpose, 2 electrical stimulators, one for each leg will stimulate SOL and TA muscles bilaterally while open-loop tonic lumbar TSCS will be applied at an intensity producing paresthesia in most of the lower-limb dermatomes Receives: Other: Activity-based rehabilitation+electrical stimulation |
| FES group | Active comparator | For the FES with VFT group, participants will receive visual feedback regarding their center of pressure location during four games with varying levels of difficulty and FES will be applied bilaterally to SOL and TA via a closed-loop system. Receives: Other: Activity-based rehabilitation+electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Balance Evaluation Systems Test (mini-BESTest)
evaluates different components of postural control including anticipatory, reactive postural control, sensory orientation, and dynamic gait. It has high test-retest reliability, concurrent and convergent validity in individuals with iSCI.
Measured: pre- immidiately post- 6 weeks follow up
10-meter Walk Test (10MWT)
performance-based measure to assess mobility and walking speed over a short distance.
Measured: pre- immidiately post- 6 weeks follow up
Motor evoked potentials (MEP)
To measure neuroplasticity, we will record changes in the MEPs for the SOL and TA induced by TMS over the leg representation of the motor cortex
Measured: pre- immidiately post- 6 weeks follow up
Secondary outcomes (2)
Activities-specific Balance Confidence (ABC) Scale
self-reported questionnaire that evaluates balance confidence while performing 16 different mobility tasks such as walking around the house, sweeping the floor, climbing up and down the stairs, walking on a ramp and negotiating escalators
Measured: pre- immidiately post- 6 weeks follow up
Falls Efficacy Scale - International (FES-I)
16-item self-reported questionnaire that measures fear of falling during basic and demanding daily life activities
Measured: pre- immidiately post- 6 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start5 Nov 2023
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kei Masani, University Health Network, Toronto
- Investigators
- Kei Masani, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940636
- Sponsor's protocol ID
- 23-5262
- Status last verified
- Mar 2026
- First submitted
- 4 Jul 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity After Incomplete SCI
- ClinicalTrials.gov ID
- NCT05940636
- Acronym / sponsor ID
- 23-5262
- Conditions
- Spinal Cord Injuries, Muscle Pareses, Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people with partial damages in their spinal cord (iSCI) have physical impairments such as muscle paralysis in legs which make standing balance difficult. Poor balance control often leads to falls, injuries, and hospitalization. Therefore, improvement of standing balance is an important therapeutic goal for these individuals. Our team has shown that a therapy called visual feedback training (VFT) can improve standing balance by allowing individuals with iSCI to actively participate and follow visual feedback of their body sway on a screen like a computer game. We have also found that the application of low-energy electrical pulses to weak muscles called functional electrical stimulation (FES) during VFT can enhance the training effects. Recently, transcutaneous spinal cord stimulation (TSCS) has been discussed as a promising technique to further promote the rehabilitation effects after SCI by enhancing the connectivity between the brain and spinal cord and within the spinal pathways. However, to date, the potential of combining the two techniques (TSCS+FES) to improve the standing balance remains unknown. In this study, through the completion of a clinical trial, we will investigate the effects of an intervention that combines lumbar TSCS with FES of ankle muscles during VFT on the functional and neurophysiological outcomes in individuals living with iSCI. Participants will be randomly allocated to receive combined TSCS with FES or FES alone during VFT for 12 training sessions over 4 weeks. We expect that the new therapy would further improve balance and strengthen the neural connections between the brain and muscles. The expected changes in the neural connections will be measured by recording electrical signals from the lower limb muscles following stimulation of the motor region of the brain. Results of this study will be used for a larger-scale study in people with iSCI to improve balance and reduce falls during their daily life activities.
Detailed description
This is a single-center, randomized controlled trial to test the effects of a novel neuromodulation program on balance performance and neuroplasticity in individuals with iSCI. Participants will be randomly assigned to 2 equal groups labeled as (1) FES with VFT, and (2) combined neuromodulation with VFT. They will complete 8 training sessions over 4 weeks (2 sessions/week). For the FES with VFT group, participants will receive visual feedback regarding their center of pressure location during four games with varying levels of difficulty and FES will be applied bilaterally to SOL and TA via a closed-loop system. Each exercise will be completed 3 times per training session. For the combined neuromodulation with VFT group, the sub-motor threshold, open-loop TSCS will be coupled with closed-loop FES of ankle muscles during VFT. For this purpose, 2 electrical stimulators, one for each leg will stimulate SOL and TA muscles bilaterally while open-loop tonic lumbar TSCS will be applied at an intensity producing paresthesia in most of the lower-limb dermatomes. The range of FES stimulation intensity will vary between the minimal contraction threshold and 80% of the maximal tolerable threshold for each participant during games depending on the instant location of the participant's center of pressure and the location of the desired target during the game. All dependent variables will be assessed prior, immediately after, and 6-weeks after the end of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| FES+TSCS (combined) neuromodulation group | Experimental | Other: Activity-based rehabilitation+electrical stimulationFor the combined neuromodulation with VFT group, the sub-motor threshold, open-loop TSCS will be coupled with closed-loop FES of ankle muscles during VFT. For this purpose, 2 electrical stimulators, one for each leg will stimulate SOL and TA muscles bilaterally while open-loop tonic lumbar TSCS will be applied at an intensity producing paresthesia in most of the lower-limb dermatomes |
| FES group | Active comparator | Other: Activity-based rehabilitation+electrical stimulationFor the FES with VFT group, participants will receive visual feedback regarding their center of pressure location during four games with varying levels of difficulty and FES will be applied bilaterally to SOL and TA via a closed-loop system. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A traumatic or non-traumatic, non-progressive motor iSCI [American Spinal Injury Association Impairment Scale (AIS) rating of C or D];
- More than 1-year post-injury;
- ≥18 years old;
- BBS score <46;
- Free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke)
Key exclusion criteria (8 listed)
- Neurological lesion levels below T12 ;
- Severe spasticity in the legs;
- Contractures in the lower extremities that prevent achieving a neutral hip and ankle position, or extended knee;
- Peripheral nerve damage in the legs (i.e. leg muscles unresponsive to electrical stimulation);
- A pressure sore (>grade 2) on the pelvis or trunk where the safety harness is applied;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity-based rehabilitation+electrical stimulationBalance training will occur three times per week for four weeks, totaling 12 two-hour sessions. In both groups, you will be asked to stand on a force plate while playing visual feedback training (VFT) games as part of the standing balance training. A force plate is similar to a bathroom scale that you can stand on which measures your body sway during movement. Visual feedback training (VFT) is a type of activity that includes weight-shifting movements in the upright stance. VFT will be done in both groups. There will be different games as shown in figure 1 and the order of the games will be randomly chosen in each session. During each game, there will be targets that will be presented on the screen and you will have to navigate toward them . You will be able to rest between games as needed. | Other | FES group, FES+TSCS (combined) neuromodulation group |
Primary outcome
Mini-Balance Evaluation Systems Test (mini-BESTest)
Time frame: pre- immidiately post- 6 weeks follow up
evaluates different components of postural control including anticipatory, reactive postural control, sensory orientation, and dynamic gait. It has high test-retest reliability, concurrent and convergent validity in individuals with iSCI.
10-meter Walk Test (10MWT)
Time frame: pre- immidiately post- 6 weeks follow up
performance-based measure to assess mobility and walking speed over a short distance.
Motor evoked potentials (MEP)
Time frame: pre- immidiately post- 6 weeks follow up
To measure neuroplasticity, we will record changes in the MEPs for the SOL and TA induced by TMS over the leg representation of the motor cortex
2 secondary outcomes
Activities-specific Balance Confidence (ABC) Scale
Time frame: pre- immidiately post- 6 weeks follow up
Falls Efficacy Scale - International (FES-I)
Time frame: pre- immidiately post- 6 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kei Masani, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity-based rehabilitation+electrical stimulation in people with Spinal Cord Injuries and Muscle Pareses, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Balance Evaluation Systems Test (mini-BESTest) (time frame: pre- immidiately post- 6 weeks follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.