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.
Be a resident of either British Columbia (for Vancouver Site) with an active provincial medical service plan or Ukraine (for Ukraine Site) Age between 19 and 65 years at the time of consent
Subacute (time since injury 3-6 months) or chronic (time since injury 12+ months) SCI
ASIA Impairment Scale (AIS) A or B at spinal segments C5-T10
Documented impaired LUT function
Clinically significant depression with thoughts of suicidal ideation (PHQ-9 total score above 20) or debilitating PTSD (PCL-5 total score above) or as judged by the investigator.
History of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery.
Exhibits signs of lower motor neuron injury (i.e., concomitant conus medullaris/cauda equina injury).
History of intradetrusor or intrasphincter onabotulinumtoxinA injections within 9 months of baseline visit.
Parallel
Spinal COrd NEuromodulation™ (SCONE™) for transcutaneous spinal cord stimulation (TSCS)
DeviceThe SCONE™ class II investigational device is a non-invasive central nervous system (CNS) stimulator (electrical continence device) designed to provide transcutaneous spinal cord stimulation for the improvement of symptoms of bladder dysfunction associated with centrally-mediated NLUTD.
Change in Neurogenic Bladder Symptom Score (NBSS)
Change in Neurogenic Bladder Symptom Score (NBSS) by 10-points at 8 weeks of therapy. The NBSS is a comprehensive and validated survey that quantifies symptoms of neurogenic lower urinary tract dysfunction (NLUTD). A minimum change of 5 points on the NBSS demonstrates clinically meaningful improvement for this patient population as established in the literature.
Mean change in voiding efficacy by at least 50%
Mean change in voiding efficacy by at least 50% related to bladder function as measured during urodynamic investigation (UDI). TSCS's efficacy assessment on lower urinary tract (LUT) function; The bladder will be prefilled without eliciting detrusor overactivity or autonomic dysreflexia (AD). Then, TSCS will be delivered in bursts (i.e., 60 seconds) interspersed with rest periods (i.e., 30 seconds) to improve voiding efficiency. It has been demonstrated that sacral neuromodulation can result in improvements in LUT function by over 50% compared to baseline.
Mean change in time needed for bowel movement (TNFBM) by at least 50%
Mean change in time needed for bowel movement (TNFBM) by at least 50% related to bowel function as measured by the TNFBM. A conventional bowel routine (suppository use only) will be assessed three times over a one-week period. To assess and compare TNFBM, the time from 'suppository insertion' to 'when bowel evacuation is completed' at the individual's home will be recorded. Ninety-eight percent (98%) of individuals with SCI report at least one bowel issue, such as time needed for bowel management lasting up to 2 hrs., with over 60% reporting that bowel dysfunction adversely impacts their health related quality-of-life.
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University of British Columbia
Lead sponsor
United States Department of Defense
Collaborator
Rivne Regional War Veterans Hospital, Spinal Cord Injury Rehabilitation Center
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
