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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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 moreSecondary study objectives
Cadence
Lower Extremity Motor Score (LEMS)
Postural sway test
+6 moreOther 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.
Effects of high frequency repetitive transcranial magnetic stimulation on KCC2 expression in rats with spasticity following spinal cord injury.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition affecting my leg function due to bone or nerve issues.I don't have conditions like severe bone issues or implanted electronic devices that prevent FES use.My spinal cord injury is not getting worse.I can walk 10 meters by myself without any help.I don't have metal implants, a history of seizures, or cochlear implants.I have a spinal cord injury that is not fully paralyzing, and it's been over a year since the injury.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
- Group 2: Control group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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