Actively Recruiting
Noninvasive Spinal Cord Stimulation for Early SCI
Led by University of British Columbia · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The investigators are looking to determine the safety and efficacy of non-invasive transcutaneous spinal cord stimulation (TSCS) in promoting recovery of lower urinary tract (LUT), bowel, sexual, and cardiovascular function, as well as spasticity in individuals with subacute and chronic SCI (time since injury 3-6 months) and the impact on quality of life. The study will be conducted at two sites; site 1 in Canada and site 2 in the Ukraine. Up to 60 subjects will be enrolled; 10 adults at the ICORD, University of British Columbia (UBC), Vancouver, Canada site and 50 adults at the Rivne Regional War Veterans Hospital, Rivne, Ukraine. Eligible participants will be randomized (1:1 ratio) either to Group 1 (G1) or Group 2 (G2). G1 will receive therapeutic TSCS for 8 weeks (3 times per week; 1 hour per session) in conjunction with conventional rehabilitation (3-4 hours per day; 5 days per week). G2 will receive 8 weeks of sham stimulation in conjunction with conventional rehabilitation. After 8 weeks, G2 will cross over and receive therapeutic TSCS for 8 weeks, whereas G1 will continue to receive TSCS therapy for another 8 weeks, for a total of 16 weeks. Eligible participants enrolled into the study will attend fifty eight (58) visits for assessments, therapy, and follow-up. The expected duration of study participation for each participant will be 33 weeks.
CONDITIONS
Official Title
Noninvasive Spinal Cord Stimulation for Early SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be a resident of British Columbia (Canada) or Ukraine with an active provincial medical service plan
- Aged between 19 and 65 years at the time of consent
- Have a subacute (3-6 months since injury) or chronic (12+ months since injury) spinal cord injury
- Motor-complete spinal cord injury classified as ASIA Impairment Scale A or B at spinal segments C5-T10
- Documented impaired lower urinary tract function
- Women of childbearing potential must have a negative pregnancy test before baseline and agree to use effective contraception during the study and for 28 days after
- Sexually active males with female partners of childbearing potential must agree to use effective contraception during the study and for 28 days after
- Provide informed consent
- Agree to comply with all visits, assessments, established bowel and urinary routines, and not start new bowel or urinary medications without notifying the study investigator
You will not qualify if you...
- Clinically significant depression with suicidal thoughts or severe PTSD, or as judged by the investigator
- History of bladder augmentation, urinary stoma, or prior bladder surgery
- Signs of lower motor neuron injury such as conus medullaris or cauda equina injury
- Received intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months before baseline
- Use of medications or treatments interfering with study outcomes as judged by the investigator
- Cognitive, social, psychological, or other conditions that prevent participation or completion as judged by the investigator
- Severe acute medical issues interfering with testing (e.g., stage 3/4 pressure ulcers, uncontrolled diabetes)
- Contraindications for TSCS including implanted cardiac pacemaker, metal implants in trunk or spinal cord, intrathecal delivery systems like baclofen pump, or implanted neuromodulators
- Any medical condition that poses risk as determined by the investigator
- Participation in or plans to participate in another research study that may interfere with this study's endpoints
AI-Screening
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Trial Site Locations
Total: 1 location
1
Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
Research Team
A
Andrea Maharaj, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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