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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
Study Summary
This trial will explore if using both rTMS and FES together can improve lower body function for people 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-emergent adverse events
Number of dropouts in each group
Number of sessions attended by each participant
+3 moreSecondary outcome measures
Cadence
Lower Extremity Motor Score (LEMS)
Postural sway test
+6 moreOther outcome measures
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
Find a Location
Who is running the clinical trial?
Western University, CanadaLead Sponsor
239 Previous Clinical Trials
56,907 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: Control group
- Group 2: Treatment 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the major aims of this investigation?
"This 8-week trial will be assessing the proportion of recruited participants from those initially screened as its primary endpoint. Additionally, secondary endpoints include step length, width and cadence obtained through pressure sensor gait mats."
Answered by AI
Are there any volunteer opportunities available for participation in this research protocol?
"According to the information hosted on clinicaltrials.gov, there are no open spots in this medical trial at present; although it was initially posted and last updated on August 1st 2023, the study is not presently recruiting volunteers. However, 368 other trials are currently accepting applicants."
Answered by AI
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