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Behavioural Intervention

Combined Neuromodulation Therapy for Spinal Cord Injury

N/A
Waitlist Available
Led By Kei Masani, PhD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre- immidiately post- 6 weeks follow up
Awards & highlights

Study Summary

This trial will study how combining electrical pulses and visual feedback can help those with partial spinal cord damage improve standing balance & reduce falls.

Who is the study for?
This trial is for adults over 18 with partial spinal cord injury (iSCI) who have muscle paralysis affecting balance but no other conditions impacting walking or balance. They must be at least one year post-injury, not pregnant, free from epilepsy, and without severe spasticity or nerve damage in the legs.Check my eligibility
What is being tested?
The study tests a new therapy combining visual feedback training (VFT), functional electrical stimulation (FES) of ankle muscles, and transcutaneous spinal cord stimulation (TSCS). Participants will either receive TSCS+FES during VFT or just FES during VFT across 12 sessions to improve balance and neural connections.See study design
What are the potential side effects?
Potential side effects may include discomfort from electrical stimulation, skin irritation at electrode sites, muscle fatigue after treatment sessions, and possible mild pain due to the intensity of rehabilitation exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My balance and mobility score is less than 46.
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I don't have any conditions besides SCI affecting my walking or balance.
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My spinal cord injury is moderate to mild (AIS C or D).
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I am 18 years old or older.
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It has been over a year since my injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- immidiately post- 6 weeks follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre- immidiately post- 6 weeks follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
10-meter Walk Test (10MWT)
Mini-Balance Evaluation Systems Test (mini-BESTest)
Motor evoked potentials (MEP)
Secondary outcome measures
Activities-specific Balance Confidence (ABC) Scale
Falls Efficacy Scale - International (FES-I)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FES+TSCS (combined) neuromodulation groupExperimental Treatment1 Intervention
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
Group II: FES groupActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,499 Total Patients Enrolled
Kei Masani, PhDPrincipal InvestigatorUniversity Health Network, Toronto

Media Library

Combined Neuromodulation Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05940636 — N/A
Spinal Cord Injury Research Study Groups: FES+TSCS (combined) neuromodulation group, FES group
Spinal Cord Injury Clinical Trial 2023: Combined Neuromodulation Therapy Highlights & Side Effects. Trial Name: NCT05940636 — N/A
Combined Neuromodulation Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05940636 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile meet the requirements to enter this research project?

"To qualify for inclusion in this medical trial, candidates must be 18-80 years old and have a spinal cord injury. A total of 20 individuals will take part in the study."

Answered by AI

Is the minimum enrollment age for this trial below 65 years old?

"Those hoping to join this clinical trial must have an age between 18 and 80. However, there are 39 alternative trials specifically for minors and 316 studies open to seniors."

Answered by AI

Is this trial recruiting participants currently?

"According to the data found on clinicaltrials.gov, this research endeavour is no longer seeking participants; however, there are 368 other trials actively recruiting at this time. This study was initially posted September 1st 2023 and last updated July 4th 2023."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity
Kei Masani 2023. "A Novel Combined Neuromodulation Therapy to Enhance Balance and Neuroplasticity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05940636.
~9 spots leftby Nov 2024
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