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).
Resident of British Columbia, Canada with active provincial medical services plan.
Male or female, 19-60 years of age.
Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
>1-year post injury, at least 6 months from any spinal surgery.
Ventilator dependent.
Signs of lower motor neuron damage (i.e. concomitant conus medullaris/cauda equina injury).
Severe anemia or hypovolemia as measured by hematocrit via blood test in the last six months.
History of cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
Parallel
TESCoN or SCONE device - Thoracic stimulation
DeviceTCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the thoracic spinal cord.
TESCoN or SCONE device - Lumbosacral stimulation
DeviceTCSCS will be delivered using a non-invasive central nervous system stimulator (TESCoN or SCONE, SpineX Inc., CA, USA). The stimulation site will be over the lumbosacral spinal cord.
Targeted TCSCS map modulate resting blood pressure (BP)
Using continuous beat-by beat BP monitoring via finger photoplethysmography during TCSCS, the researchers will identify the location and stimulation parameters to increase and decrease resting BP. Stimulation site will be either on the thoracic spinal cord (T7-T12) or the lumbosacral spinal cord (L1 - L3). Stimulation will be applied at various frequencies ranging between 1Hz and 90Hz. The outcome is an individualized TCSCS map (i.e. location and stimulation parameters) with change in systolic BP at rest during TCSCS.
Targeted TCSCS map to activate skeletal muscles and pelvic floor muscles
Using surface electromyography (EMG), the researchers will identify the motor threshold for skeletal muscles known to be involved in lower urinary tract, bowel and sexual control by delivering TCSCS at various spinal cord segments (T7 to conus medullaris). The outcome is an individualized TCSCS map (i.e. location and stimulation parameters) with pertinent motor thresholds for TCSCS-driven surface EMG.
Immediate change in BP during the head up tilt test (HUTT)
During HUTT, participants will be passively moved to approximately 60° upright stand position by the investigators using the tilt table. Using TCSCS to activate spinal sympathetic circuitry and mitigate low resting BP and orthostatic hypotension (OH), and continuous beat-by beat BP monitoring via finger photoplethysmography, researchers will test the safety and efficacy of short-term TCSCS in reproducibly improving OH triggered by HUTT.
Change in BP during the head up tilt test (HUTT) from baseline to after completion of 8 weeks of TCSCS
Using TCSCS and continuous beat-by beat BP monitoring via finger photoplethysmography, researchers will test the safety and efficacy of long-term TCSCS in improving OH triggered by HUTT.
Immediate change in cerebral blood flow (CBF) measured by trans-cranial doppler (TCD) during HUTT
TCD is a non-invasive ultrasound technique used to measure real-time CBF velocity. Researchers will test the safety and efficacy of short-term TCSCS in reproducibly improving CBF during HUTT.
Change in CBF measured by TCD during HUTT from baseline to after completion of 8 weeks of TCSCS
Researchers will test the safety and efficacy of long-term TCSCS in improving CBF during HUTT.
Change in CBF measured by TCD during HUTT from baseline to 8 weeks after TCSCS cessation
Researchers will test the safety and efficacy of TCSCS in improving CBF during HUTT after cessation of therapy.
Immediate change in performance on the verbal fluency test (VFT) during HUTT
Phonetic/letter fluency, specifically total number of words, will be measured using the verbal fluency test (VFT). Researchers will test the safety and efficacy of short-term TCSCS in reproducibly improving cognitive function during HUTT.
Frequency of urinary incontinence will be measured using The Incontinence-Quality of Life (I-QoL) questionnaire.
Assessment of urinary incontinence will be performed to assess the impact of long term TCSCS on this measure. The scale is a 100 point scale where 0 is most severe incontinence.
Neurogenic bladder symptoms will be measured using the Neurogenic Bladder Symptom Score (NBSS).
Assessment of neurogenic bladder symptoms will be performed to assess the impact of long term TCSCS on this measure. The score measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23), with higher scores representing worse symptoms.
Frequency of fecal incontinence will be measured using the modified Wexner Fecal Incontinence Score (WIS).
Assessment of fecal incontinence will be performed to assess the impact of long term TCSCS on this measure. Scores can range from 0-20, with a higher score representing greater incontinence.
Neurogenic bowel symptoms will be measured using the Neurogenic Bowel Dysfunction (NBD) score.
Assessment of neurogenic bowel symptoms will be performed to assess the impact of long term TCSCS on this measure. Scores can range from 0-47, with a higher score representing more severe dysfunction.
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
United States Department of Defense
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
