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.
NCT Number: NCT05369520
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).
Interested in participating?
Request Info19 year–60 year
All sexes
Interventional
Not applicable
Blusson Spinal Cord Centre, Vancouver, British Columbia, Canada
This is a pilot clinical trial to explore the efficacy of TCSCS (proof-of-concept) in mitigating crucial autonomic dysfunctions that impact the health-related quality of life of individuals with SCI. A total of 30 eligible participants will be recruited and attend forty-two visits. All experiments will be performed at ICORD (Primary site) and the Brenda and David McLean Integrated Spine Clinic (SCI clinic), with the exception of anorectal manometry testing conducted at the Gastroenterology Clinic, St Paul's Hospital (GI clinic).
Following completion of screening and signing informed consent forms (visit 1), participants will undergo spatiotemporal mapping of spinal cord segments known to be involved in blood pressure, lower urinary tract and bowel control (visit 2). Following mapping, all individuals will undergo baseline functional assessments with and without TCSCS during 5 visits (visits 3-7), over a period of 4 weeks. To minimize the order effect, the functional assessments will be performed in a randomized order. Following baseline assessments, using a randomized counter-balanced approach, individuals will be allocated in two distinct pathways; the participants in Groups 1 and 2 will receive 8 weeks of TCSCS (3 times/week) at either mid/low thoracic or lumbosacral spinal cord levels respectively (visits 8- 31). Following long-term TCSCS, participants will undergo functional assessments during 5 visits (visits 32- 36) over a period of 4 weeks. In order to evaluate the persistent effects of TCSCS, all assessments will be repeated 8 weeks after cessation of the therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TCSCS 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.
TCSCS 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.
Time frame: Week 1-2 (once)
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.
Time frame: Week 1-2 (once)
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.
Time frame: Week 3 - 6 (once)
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.
Time frame: Week 15-18 (once)
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.
Time frame: Week 27-30 (once)
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 after cessation of therapy.
Time frame: Week 3 - 6 (once)
DARS is a routine procedure to initiate a bowel routine. The participant will lay on their right side and DARS will be delivered via an index finger inserted into the rectum, applying gentle pressure for 30-60s. Utilizing TCSCS to inhibit nociceptive afferent and continuous beat-by beat BP monitoring via finger photoplethysmography, researchers will test the safety and efficacy of short-term TCSCS in reproducibly improving autonomic dysreflexia (AD) triggered by DARS.
Time frame: Week 15-18 (once)
Utilizing TCSCS and continuous beat-by beat BP monitoring via finger photoplethysmography, researchers will test the safety and efficacy of long-term TCSCS in improving AD triggered by DARS.
Time frame: Week 27-30 (once)
Utilizing TCSCS and continuous beat-by beat BP monitoring via finger photoplethysmography, researchers will test the safety and efficacy of TCSCS in improving AD triggered by DARS after cessation of therapy.
Time frame: Week 3 - 6 (once)
ARM is well-established methodology that provides a direct assessment of anal sphincter pressure and anorectal coordination during simulated defecation. The test is performed by inserting a catheter, that contains a probe embedded with pressure sensors, through the anus and into the rectum. Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing average max resting and squeeze pressure (mmHg).
Time frame: Week 3 - 6 (once)
Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing length of high pressure anal canal zone (cm).
Time frame: Week 3 - 6 (once)
Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing recto-anal inhibitory reflex.
Time frame: Week 3 - 6 (once)
Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing rectal sensation (mL).
Time frame: Week 15-18 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of long-term TCSCS in changing average max resting and squeeze pressure (mmHg).
Time frame: Week 15-18 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of long-term TCSCS in changing length of high pressure anal canal zone (cm).
Time frame: Week 15-18 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of long-term TCSCS in changing rectal sensation (mL).
Time frame: Week 15-18 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of long-term TCSCS in changing recto-anal inhibitory reflex.
Time frame: Week 27-30 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing average max resting and squeeze pressure (mmHg).
Time frame: Week 27-30 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing length of high pressure anal canal zone (cm).
Time frame: Week 27-30 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing recto-anal inhibitory reflex.
Time frame: Week 27-30 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing rectal sensation (mL).
Time frame: Week 3 - 6 (once)
Standard clinical procedures for UDI, including cystometry with water at 21°C and a filling rate of < 30 mL per minute through a 6F double lumen catheter with the participants in the supine position, provides a direct assessment of voiding and storage function. Abdominal pressure will be measured with a 10F intrarectal balloon catheter. Filling will be stopped when the participants report a sensation of fullness. Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing intravesical pressure at first sensation (mmHg).
Time frame: Week 3 - 6 (once)
Filling will be stopped at the moment of urine leakage. Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing intravesical pressure at leakage point (mmHg).
Time frame: Week 3 - 6 (once)
Filling will be stopped at the moment of discomfort/per the request of patient. Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing intravesical pressure at maximal volume (mmHg).
Time frame: Week 15-18 (once)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of long-term TCSCS in changing intravesical pressure at first sensation (mmHg).
Time frame: Week 15-18 (once)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of long-term TCSCS in changing intravesical pressure at leakage point (mmHg).
Time frame: Week 15-18 (once)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of long-term TCSCS in changing intravesical pressure at maximal volume (mmHg).
Time frame: Week 27-30 (once)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of TCSCS in changing intravesical pressure at first sensation (mmHg).
Time frame: Week 27-30 (once)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of TCSCS in changing intravesical pressure at leakage point (mmHg).
Time frame: Week 27-30 (once)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of TCSCS in changing intravesical pressure at maximal volume (mmHg).
Time frame: Week 3 - 6 (once)
Genital vibration will be applied by an experienced physician using one or more handheld vibrators placed about the glans penis or the clitoral area with an amplitude of 1.0-3.5 mm and a frequency of 70-100 Hz. Utilizing TCSCS to inhibit nociceptive afferent and continuous beat-by beat BP monitoring via finger photoplethysmography, researchers will test the safety and efficacy of short-term TCS in reproducibly improving AD triggered by vibrostimulation.
Time frame: Week 15-18 (once)
Utilizing TCSCS and continuous beat-by beat BP monitoring via finger photoplethysmography, researchers will test the safety and efficacy of long-term TCSCS in improving AD triggered by vibrostimulation.
Time frame: Week 27-30 (once)
Utilizing TCSCS to inhibit nociceptive afferent and continuous beat-by beat BP monitoring via finger photoplethysmography, researchers will test the safety and efficacy of TCSCS in improving AD triggered by vibrostimulation.
Time frame: Week 3 - 6 (once)
The wireless motility capsule will be ingested and pass naturally through the GI tract, and data will be sent wirelessly to the data receiver. Researchers will use the collected data to assess baseline transit times.
Time frame: Week 15-18 (once)
Utilizing TCSCS and the wireless motility capsule, researchers will test the safety and efficacy of long-term TCSCS in improving transit times.
Time frame: Week 27-30 (once)
Utilizing TCSCS and the wireless motility capsule, researchers will test the safety and efficacy of TCSCS in improving transit times after cessation of therapy.
Time frame: Week 3 - 6 (once)
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.
Time frame: Week 15-18 (once)
Researchers will test the safety and efficacy of long-term TCSCS in improving CBF during HUTT.
Time frame: Week 27-30 (once)
Researchers will test the safety and efficacy of TCSCS in improving CBF during HUTT after cessation of therapy.
Time frame: Week 3 - 6 (once)
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.
Time frame: Week 15-18 (once)
Researchers will test the safety and efficacy of long-term TCSCS in improving phonetic/letter fluency using the VFT.
Time frame: Week 27-30 (once)
Researchers will test the safety and efficacy of TCSCS in improving phonetic/letter fluency after cessation of therapy.
Time frame: Week 3 - 6 (once)
Ability to inhibit cognitive interference, specifically completion time, will be measured using the Stroop Color and Word (SCW) test. Researchers will test the safety and efficacy of short-term TCSCS in reproducibly improving completion time of the SCW.
Time frame: Week 15-18 (once)
Researchers will test the safety and efficacy of short-term TCSCS in reproducibly improving completion time of the SCW.
Time frame: Week 27-30 (once)
Researchers will test the safety and efficacy of short-term TCSCS in reproducibly improving completion time of the SCW after cessation of therapy.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
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.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
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.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
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.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
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.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
Participants will be asked to record the time from 'suppository insertion' to 'when bowel evacuation is completed', during their regular bowel movement at home.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
This measure of sexual function will be used to assess whether sexual function is impacted by TCSCS. Scores can range from 5-25, with higher scores representing greater function.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
This measure of sexual function will be used to assess whether sexual function is impacted by TCSCS. Scores can range from 2-36, with higher scores representing greater function.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
This measure of sexual function will be used to assess whether sexual function is impacted by TCSCS.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
The FSDS is a 13-item self-report measure of sexually related personal distress in women. The 13 items of the scale are scored on a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is calculated as the sum of the responses and ranges from 0 to 52, with higher scores indicating a greater level of distress. A score of ≥11 serves as a cut-off value for diagnosing women with sexual distress.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
The ORS is a 28 item self-report measure of phenomenological sensations associated with orgasm in men and women. Items are scored from 0 (not at all) 5 (extremely), with total scores ranging from 0 to 140, and higher scores indicating better function.
Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)
The SF-36 consists of 8 domains pertaining to the respondents' experiences in the last 4 weeks. Each of the 8 summed scores is linearly transformed onto a scale from 0 (negative health) to 100 (positive health) to provide a score for each subscale.
Contact information is provided by the study sponsor or research team.
Andrea L. Maharaj, BSc
CONTACT
Soshi Samejima, PhD
CONTACT
University of British Columbia
Other
Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice
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