This study will measure the effect of non-invasive spinal cord stimulation on the recovery of bladder, bowel, sexual, heart, motor function, and muscle spasticity for people living with spinal cord injury (SCI). The study will also examine the impact of spinal cord stimulation on overall quality-of-life.
The study protocol involves 58 visits for assessments, therapy, and follow-up, for a total of about 33 weeks.
If eligible, you will be randomly assigned to receive non-invasive spinal cord stimulation (Group 1) or sham therapy (Group 2) for 8 weeks (1.5 hours, 3 times a week) together with conventional rehabilitation. After 8 weeks, Group 2 will receive non-invasive spinal cord stimulation for 8 weeks, and Group 1 will continue to receive stimulation for another 8 weeks for a total of 16 weeks. Health Canada has not approved the sale or use of this medical device for autonomic function recovery in individuals with spinal cord injury, although they have allowed its use in this clinical study. You will be asked to complete questionnaires and physiological assessments related to the study goals, including bladder and bowel assessments.
Why should you participate in this study?
The evolution of transcutaneous spinal cord stimulation (TSCS) as a non-invasive alternative to surgical implants is supported by electromyography (EMG) research findings. EMG studies show that the stimulation’s modulatory effects are driven by the activation of sensory information to the brain rather than direct recruitment of spinal gray matter neurons. EMG findings indicate that invasive and non-invasive stimulation techniques show near identical EMG responses which suggests that both techniques activate common neural structures. Our research team and others have shown that non-invasive TSCS can restore cardiovascular and lower urinary tract function in individuals with SCI.
You may be eligible to participate in this study if you:
- Are between 19 and 65 years of age at the time of consent
- Reside in the Lower Mainland
- Have subacute SCI (time since injury: 3-6months) at ASIA Impairment Scale (AIS) A or B, at spinal segments C5-T10
- Have documented impaired lower urinary tract function
- Provide informed consent.
- Agree to comply with all planned visits and assessments and adhere with established bowel and lower urinary tract routines.
- Refrain from initiation of new medications for bowel and/or lower urinary tract management prior to notifying the Principal Investigator of this study.
People of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- must have a confirmed negative pregnancy test prior to the baseline visit.
- must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.
You may not be eligible to participate if you:
- Experience clinically significant depression with thoughts of suicidal ideation (PHQ-9 total score above 20) or debilitating PTSD (PCL-5 total score above 31-33) or as judged by the investigator.
- Have a history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
- Exhibit signs of lower motor neuron injury (i.e., concomitant conus medullaris/cauda equina injury).
- Have a history of intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline visit.
- Concurrently use any medication or treatment that in the opinion of the investigator interferes with study outcomes.
- Have cognitive impairments, social/psychological problems, or other comorbid conditions that, in the opinion of the Investigator, will preclude them from participation and completion of the study.
- Have severe acute medical issues that interfere with testing (e.g., stage 3/4 pressure ulcers, uncontrolled diabetes).
- Have medical condition that may put the participant at risk as determined by the investigator.
- Participate in, or plan to participate in, another research study that may interfere with the study endpoints.
- Have contraindications for TSCS, such as:
- Implanted cardiac pacemaker
- Implanted metal in the trunk or spinal cord
- Intrathecal delivery system (e.g., baclofen pump)
- Implanted central or peripheral neuromodulator
This study will take place at the ICORD/Blusson Spinal Cord Centre (818 West 10th Avenue, Vancouver)
Time commitment: 58 visits for assessments, therapy and follow-up, for a total of about 33 weeks.
For more information or to sign up to participate, please contact the study coordinator Andrea Maharaj by email or by phone at (604) 675-8856
