Trial · NCT05369520
Registered outcomes55
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 55
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Targeted TCSCS map modulate resting blood pressure (BP) | 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. |
| Primary | Targeted TCSCS map to activate skeletal muscles and pelvic floor muscles | 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. |
| Primary | Immediate change in BP during the head up tilt test (HUTT) | 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. |
| Primary | Change in BP during the head up tilt test (HUTT) from baseline to after completion of 8 weeks of TCSCS | 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. |
| Primary | Change in BP during the head up tilt test (HUTT) from baseline to 8 weeks after cessation of TCSCS | 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. |
| Primary | Immediate change in BP during digital anorectal stimulation (DARS) | 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. |
| Primary | Change in BP during digital anorectal stimulation (DARS) from baseline to after completion of 8 weeks of TCSCS | 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. |
| Primary | Change in BP during digital anorectal stimulation (DARS) from baseline to 8 weeks after cessation of TCSCS | 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. |
| Primary | Immediate change in rectal pressure measured by anorectal manometry (ARM) | 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). |
| Primary | Immediate change in high pressure anal canal zone measured by ARM | 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). |
| Primary | Immediate change in recto-anal inhibitory reflex measured by ARM | Week 3 - 6 (once) | Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing recto-anal inhibitory reflex. |
| Primary | Immediate change in rectal sensation measured by ARM | Week 3 - 6 (once) | Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing rectal sensation (mL). |
| Primary | Change in rectal pressure measured by ARM from baseline to after completion of 8 weeks of TCSCS | 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). |
| Primary | Change in high pressure anal canal zone measured by ARM from baseline to after completion of 8 weeks of TCSCS | 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). |
| Primary | Change in rectal sensation measured by ARM from baseline to after completion of 8 weeks of TCSCS | Week 15-18 (once) | Utilizing TCSCS and ARM, researchers will test the safety and efficacy of long-term TCSCS in changing rectal sensation (mL). |
| Primary | Change in recto-anal inhibitory reflex measured by ARM from baseline to after completion of 8 weeks of TCSCS | 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. |
| Primary | Change in rectal pressure measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS | 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). |
| Primary | Change in high pressure anal canal zone measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS | 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). |
| Primary | Change in recto-anal inhibitory reflex measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS | Week 27-30 (once) | Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing recto-anal inhibitory reflex. |
| Primary | Change in rectal sensation measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS | Week 27-30 (once) | Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing rectal sensation (mL). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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