Actively Recruiting
Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury
Led by University of British Columbia · Updated on 2025-12-08
30
Participants Needed
2
Research Sites
208 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
This study is a pilot clinical trial to explore the efficacy of transcutaneous spinal cord stimulation (TCSCS) (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with spinal cord injury (SCI).
CONDITIONS
Official Title
Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Resident of British Columbia, Canada with active provincial medical services plan
- Male or female aged 19 to 60 years
- Chronic traumatic spinal cord injury at or above the T6 spinal segment
- More than 1 year post injury and at least 6 months since any spinal surgery
- American Spinal Injury Association Impairment Scale (AIS) A or B
- Stable management of spinal cord related clinical issues such as spasticity
- Experience bladder, bowel, or sexual dysfunction
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection interfering with testing
- Women of childbearing potential must have a negative pregnancy test before baseline and use adequate contraception or abstinence during the trial and for 28 days after
- Sexually active males with partners of childbearing potential must use adequate contraception or abstinence during the trial and for 28 days after
- Able to provide informed consent
- Willing and able to comply with all clinic visits and study procedures
- Able to understand and complete study questionnaires in English or with an interpreter
You will not qualify if you...
- Ventilator dependent
- Signs of lower motor neuron damage (such as conus medullaris or cauda equina injury)
- Severe anemia or low blood volume as measured by hematocrit in the past six months
- History of cardiovascular, respiratory, bladder, or kidney disease unrelated to spinal cord injury
- Presence of hydronephrosis or obstructive kidney stones
- History of seizures, epilepsy, or recurring headaches
- Clinically significant unmanaged depression or ongoing drug abuse
- Having an intrathecal baclofen pump
- Oral baclofen dose greater than 60 mg
- Received intradetrusor or intrasphincter botulinum toxin injections within 6 months before baseline
- Implanted metal in the skull (excluding dental implants) or pacemakers, stimulators, or medication pumps in the trunk
- Previous electrode implantation surgery
- Member of the investigational team or immediate family
- Severe acute medical issues or treatments that could affect study participation
- Known allergies to both blue dye and beetroot powder
- Known or suspected gastrointestinal obstruction
- Active inflammatory bowel disease or history of bowel perforation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Blusson Spinal Cord Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
2
St Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Actively Recruiting
Research Team
A
Andrea L. Maharaj, BSc
CONTACT
S
Soshi Samejima, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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