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Procedure

Brain Stimulation + FES Cycling for Spinal Cord Injury

N/A
Recruiting
Research Sponsored by Western University, Canada
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial tests if combining brain and muscle electrical stimulation helps people with partial spinal cord injuries walk better by improving muscle strength and coordination. Functional electrical stimulation (FES) has been used to assist walking and improve muscle strength in individuals with spinal cord injuries.

Who is the study for?
This trial is for adults with incomplete spinal cord injury (SCI), classified as level C or D by the American Spinal Injury Association, who can walk 10 meters unaided. It's been at least a year since their non-progressive SCI occurred. People with other conditions affecting leg function or those with contraindications to rTMS or FES, like metal implants or severe osteoporosis, cannot participate.
What is being tested?
The study tests how effective it is to combine repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling on improving leg function in people with incomplete SCI compared to using each intervention alone. Participants are randomly assigned to different treatment groups.
What are the potential side effects?
Possible side effects of rTMS include discomfort at the stimulation site, headache, lightheadedness, and seizures in very rare cases. FES cycling may cause muscle fatigue and skin irritation beneath electrode sites.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of treatment-emergent adverse events
Number of dropouts in each group
Number of sessions attended by each participant
+3 more
Secondary study objectives
Cadence
Lower Extremity Motor Score (LEMS)
Postural sway test
+6 more
Other study objectives
Global Rating of Change (GRC) scale

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment groupExperimental Treatment2 Interventions
Participants of this group will receive active rTMS along with real FES cycling.
Group II: Control groupPlacebo Group1 Intervention
Participants of this group will receive sham rTMS along with real FES cycling.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
repetitive transcranial magnetic stimulation (rTMS)
2003
Completed Phase 2
~380

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Repetitive Transcranial Magnetic Stimulation (rTMS) enhances neural plasticity and recovery by stimulating the brain's motor cortex, which can help rewire neural pathways and improve motor function. Functional Electrical Stimulation (FES) Cycling improves muscle strength and coordination by delivering electrical impulses to muscles, causing them to contract and thus promoting muscle activity and endurance. These treatments are significant for Spinal Cord Injury patients as they target both neural and muscular recovery, potentially leading to improved mobility and quality of life.
Effects of high frequency repetitive transcranial magnetic stimulation on KCC2 expression in rats with spasticity following spinal cord injury.

Find a Location

Who is running the clinical trial?

Western University, CanadaLead Sponsor
251 Previous Clinical Trials
53,695 Total Patients Enrolled
Siobhan Schabrun, PhDStudy DirectorWestern University, Canada

Media Library

Functional Electrical Stimulation (FES) Cycling (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05975606 — N/A
Spinal Cord Injury Research Study Groups: Treatment group, Control group
Spinal Cord Injury Clinical Trial 2023: Functional Electrical Stimulation (FES) Cycling Highlights & Side Effects. Trial Name: NCT05975606 — N/A
Functional Electrical Stimulation (FES) Cycling (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975606 — N/A
~7 spots leftby Oct 2025