This study will assess the safety and effectiveness of non-invasive spinal cord stimulation in recovering cardiovascular, bladder, bowel, and sexual functions in people with spinal cord injury (SCI). We are interested in both the immediate effects (i.e., effects when the stimulation is turned on), effects after eight weeks of therapy (24 sessions), and long-term persisting effects (i.e., changes in functions when the stimulation is turned off, after several weeks of using the stimulation regularly).
The study protocol involves 42 visits for assessments, therapy, and follow-up, for a total of about 30 weeks.
If eligible, you will be randomly assigned to receive stimulation at either mid/low thoracic (Group 1) or lumbosacral (Group 2) spinal cord levels for 8 weeks (3 times/week).
Why should you participate?
There may or may not be a direct benefit to you. We hope the information obtained from this study may improve our understanding of the effects of electrical stimulation of the spinal cord in people with SCI and may lead to an alternative treatment for improving bowel, bladder, and sexual function. Health Canada has not approved the use of this device in Canada, but they have allowed it to be used in this clinical trial.
You may be eligible to participate in this study if you:
A participant must meet all of the following criteria will be eligible to participate:
1. Resident of British Columbia, Canada with an active provincial medical services plan.
2. Male or female, 19-60 years of age.
3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
4. >1-year post injury, at least 6 months from any spinal surgery.
5. American Spinal Injury Association Impairment Scale (AIS) A, B.
6. Stable management of spinal cord related clinical issues (i.e., spasticity management).
7. Experience bladder, bowel, or sexual dysfunctions.
8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
9. Must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply to female participants of childbearing potential:
A) A confirmed negative pregnancy test prior to the baseline visit.
B) Use adequate contraception, or practice complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
10. For sexually active males with female partners of childbearing potential, use adequate contraception, or practice complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
11. Must provide informed consent.
12. Willing and able to comply with all clinic visits and study-related procedures.
13. Must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator.
You may not be eligible to participate if you:
A participant who meets any of the following criteria will be ineligible to participate:
1. Ventilator dependent.
2. Severe anemia or hypovolemia.
3. History of cardiovascular, respiratory, bladder, or kidney disease unrelated to SCI or presence of hydronephrosis or presence of obstructive kidney stones.
4. History of seizures/epilepsy or recurring headaches.
5. Clinically significant, unmanaged depression or ongoing drug abuse.
6. Individuals who have received Botox injections for bladder or bowel management within 6 months of baseline.
7. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk (e.g., Intrathecal baclofen pump).
8. Past electrode implantation surgery.
9. Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator’s judgement, would adversely affect the participant’s participation in the study.
10. Known allergies or sensitivities to both blue dye and beetroot powder.
11. Known or suspected gastrointestinal obstruction.
12. Persons with active inflammatory bowel disease or a history of bowel perforation.
Time commitment: 42 visits for assessments, therapy, and follow-up, for a total of about 30 weeks.
Compensation for participation: A participant stipend is available.
This study will take place at: ICORD/Blusson Spinal Cord Centre/Brenda and David McLean Integrated Spine Clinic (818 West 10th Avenue, Vancouver, BC); and the Gastroenterology Clinic at St. Paul’s Hospital (1081 Burrard St, Vancouver, BC).
For more information or to sign up to participate, please contact study coordinator Andrea Maharaj by email or at (604) 675-8856
