ClinicalTrials.gg
RecruitingNCT05369520Updated Dec 8, 2025

Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury

An interventional study of TESCoN or SCONE device - Thoracic stimulation and TESCoN or SCONE device - Lumbosacral stimulation in Spinal Cord Injury, Autonomic Dysfunction and Sexual Dysfunction, sponsored by University of British Columbia. Recruiting at 2 sites in Canada. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-08.

Primary conditionAutonomic DysreflexiaRegistry: Spinal Cord InjuriesReclassifiedWhy we changed it
Registry
Spinal Cord Injuries — the first condition term the registry derived for this study.
ClinicalTrials.gg
Autonomic Dysreflexia
Why
  1. The study's listed conditions name Autonomic Dysreflexia, a narrower term within Spinal Cord Injuries.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 60 Years
Sex
All
01

Study summary

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).

Read the detailed description

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.

02

Conditions studied

  • Spinal Cord Injury
  • Autonomic Dysfunction
  • Sexual Dysfunction
  • Neurogenic Bladder Dysfunction
  • Neurogenic Bowel Dysfunction
  • Autonomic Dysreflexia
  • Orthostatic Hypotension

Keywords

  • Neurostimulation
  • Spinal Cord Injury
03

In context

Autonomic Dysreflexia Reclassified

30 studies on the registry are indexed under Autonomic Dysreflexia; 10 are open to participants now.

This study's planned enrollment of 30 is above the median of 22 across 23 interventional studies indexed under Autonomic Dysreflexia.

Browse Autonomic Dysreflexia studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Compared within Autonomic Dysreflexia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spinal Cord Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
19 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Resident of British Columbia, Canada with active provincial medical services plan.
  2. Male or female, 19-60 years of age.
  3. Chronic traumatic SCI (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
  4. >1-year post injury, at least 6 months from any spinal surgery.
  5. American Spinal Injury Association Impairment Scale (AIS) A, B.
  6. Stable management of spinal cord related clinical issues (i.e., spasticity management).
  7. Experience bladder, or bowel, or sexual dysfunction.
  8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
  9. For women of , not intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

    1. A confirmed negative pregnancy test prior to the baseline visit. During the trial, all women of childbearing potential will undergo urine pregnancy tests at their monthly clinic visits as outlined in the schedule of events.
    2. Use adequate , or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
    3. If using combined hormonal contraception, a stable regimen during the period of the trial and for at least 28 days after completion of treatment.
  10. For sexually active males with female partners of childbearing potential, use adequate contraception, or complete abstinence from sexual activities, during the period of the trial and for at least 28 days after completion of treatment.
  11. Must provide .
  12. Willing and able to comply with all clinic visits and study-related procedures.
  13. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).

Exclusion criteria

Exclusion Criteria:

  1. Ventilator dependent.
  2. Signs of lower motor neuron damage (i.e. concomitant conus medullaris/cauda equina injury).
  3. Severe anemia or hypovolemia as measured by hematocrit via blood test in the last six months.
  4. History of cardiovascular, respiratory, bladder, or renal disease unrelated to SCI or presence of hydronephrosis or presence of obstructive renal stones.
  5. History of seizures/epilepsy or recurring headaches.
  6. , unmanaged, depression (to be screened) or ongoing drug abuse.
  7. Intrathecal baclofen pump.
  8. Oral baclofen dose greater than 60mg.
  9. Individuals that have received intradetrusor or intrasphincter onabotulinumtoxinA injections within 6 months of baseline.
  10. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
  11. Past electrode implantation surgery.
  12. Member of the team or his/her immediate family.
  13. Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study.
  14. Known allergies or sensitivities to both blue dye and beetroot powder.
  15. Known or suspected gastrointestinal obstruction.
  16. Persons with active inflammatory bowel disease or a history of bowel perforation.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Group 1 - Thoracic stimulation

    Participants will receive 8 weeks TCSCS at the mid/low thoracic spinal cord levels.

    Device: TESCoN or SCONE device - Thoracic stimulation

  • Experimental
    Group 2- Lumbosacral stimulation

    Participants will receive 8 weeks TCSCS at the lumbosacral spinal cord levels.

    Device: TESCoN or SCONE device - Lumbosacral stimulation

Interventions

  • DeviceTESCoN or SCONE device - Thoracic stimulation

    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.

  • DeviceTESCoN or SCONE device - Lumbosacral stimulation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 1-2 (once)

  2. 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.

    Time frame: Week 1-2 (once)

  3. 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.

    Time frame: Week 3 - 6 (once)

  4. 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.

    Time frame: Week 15-18 (once)

  5. Change in BP during the head up tilt test (HUTT) from baseline to 8 weeks after cessation 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 after cessation of therapy.

    Time frame: Week 27-30 (once)

  6. Immediate change in BP during digital anorectal stimulation (DARS)

    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 3 - 6 (once)

  7. Change in BP during digital anorectal stimulation (DARS) from baseline to after completion of 8 weeks of TCSCS

    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 15-18 (once)

  8. Change in BP during digital anorectal stimulation (DARS) from baseline to 8 weeks after cessation of TCSCS

    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 27-30 (once)

  9. Immediate change in rectal pressure measured by anorectal manometry (ARM)

    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)

  10. Immediate change in high pressure anal canal zone measured by ARM

    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)

  11. Immediate change in recto-anal inhibitory reflex measured by ARM

    Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing recto-anal inhibitory reflex.

    Time frame: Week 3 - 6 (once)

  12. Immediate change in rectal sensation measured by ARM

    Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing rectal sensation (mL).

    Time frame: Week 3 - 6 (once)

  13. Change in rectal pressure measured by ARM from baseline to after completion of 8 weeks of TCSCS

    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)

  14. Change in high pressure anal canal zone measured by ARM from baseline to after completion of 8 weeks of TCSCS

    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)

  15. Change in rectal sensation measured by ARM from baseline to after completion of 8 weeks of TCSCS

    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)

  16. Change in recto-anal inhibitory reflex measured by ARM from baseline to after completion of 8 weeks of TCSCS

    Utilizing TCSCS and ARM, researchers will test the safety and efficacy of long-term TCSCS in changing recto-anal inhibitory reflex.

    Time frame: Week 15-18 (once)

  17. Change in rectal pressure measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS

    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)

  18. Change in high pressure anal canal zone measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS

    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)

  19. Change in recto-anal inhibitory reflex measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS

    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)

  20. Change in rectal sensation measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS

    Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing rectal sensation (mL).

    Time frame: Week 27-30 (once)

  21. Immediate change in intravesical pressure at first sensation measured by urodynamic investigation (UDI)

    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)

  22. Immediate change in intravesical pressure at leakage point measured by UDI

    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)

  23. Immediate change in intravesical pressure at maximal volume measured by UDI

    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 3 - 6 (once)

  24. Change in intravesical pressure at first sensation measured by UDI from baseline to after completion of 8 weeks of TCSCS

    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)

  25. Change in intravesical pressure at leakage point measured by UDI from baseline to after completion of 8 weeks of TCSCS

    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)

  26. Change in intravesical pressure at maximal volume measured by UDI from baseline to after completion of 8 weeks of TCSCS

    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 15-18 (once)

  27. Change in intravesical pressure at first sensation measured by UDI from baseline to 8 weeks after cessation of TCSCS

    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)

  28. Change in intravesical pressure at leakage point measured by UDI from baseline to 8 weeks after cessation of TCSCS

    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)

  29. Change in intravesical pressure at maximal volume measured by UDI from baseline to 8 weeks after cessation of TCSCS

    Utilizing TCSCS and UDI, researchers will test the safety and efficacy of TCSCS in changing intravesical pressure at maximal volume (mmHg).

    Time frame: Week 27-30 (once)

  30. Immediate change in BP during penile or clitoral vibrostimulation

    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 3 - 6 (once)

  31. Change in BP during penile or clitoral vibrostimulation from baseline to after completion of 8 weeks of TCSCS

    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 15-18 (once)

  32. Change in BP during penile or clitoral vibrostimulation from baseline to 8 weeks after cessation of TCSCS

    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 27-30 (once)

  33. Baseline assessment of colonic motility using the wireless motility capsule

    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 3 - 6 (once)

  34. Change in colonic motility using the wireless motility capsule from baseline to after completion of 8 weeks of TCSCS

    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 15-18 (once)

  35. Change in colonic motility using the wireless motility capsule from baseline to 8 weeks after TCSCS cessation.

    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 27-30 (once)

Secondary outcomes

  1. 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.

    Time frame: Week 3 - 6 (once)

  2. 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.

    Time frame: Week 15-18 (once)

  3. 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.

    Time frame: Week 27-30 (once)

  4. 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.

    Time frame: Week 3 - 6 (once)

  5. Change in performance on the VFT from baseline to after completion of 8 weeks of TCSCS

    Researchers will test the safety and efficacy of long-term TCSCS in improving phonetic/letter fluency using the VFT.

    Time frame: Week 15-18 (once)

  6. Change in performance on the VFT from baseline to 8 weeks after TCSCS cessation

    Researchers will test the safety and efficacy of TCSCS in improving phonetic/letter fluency after cessation of therapy.

    Time frame: Week 27-30 (once)

  7. Immediate change in performance on the Stroop Color and Word (SCW) test during HUTT

    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 3 - 6 (once)

  8. Change in performance on SCW from baseline to after completion of 8 weeks of TCSCS

    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)

  9. Change in performance on SCW from baseline to 8 weeks after TCSCS cessation

    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 27-30 (once)

Other outcomes

  1. 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.

    Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)

  2. 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.

    Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)

  3. 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.

    Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)

  4. 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.

    Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)

  5. Time Needed for Bowel Movement (TNFBM) will be measured by self-report.

    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)

  6. Participant's sexual function and satisfaction with their overall sexual life will be measured using the International Index of Erectile Function (IIEF-15).

    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)

  7. Participant's sexual function and satisfaction with their overall sexual life will be measured using the Female Sexual Function Index (FSFI).

    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)

  8. Participant's sexual function and satisfaction with their overall sexual life will be measured using a semi-structured qualitative interview.

    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)

  9. Participant's sexually related personal distress will be measured using the Female Sexual Distress Scale (FSDS).

    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)

  10. Participant's sensations associated with orgasm will be measured using the Orgasm Rating Scale (ORS).

    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)

  11. Participant's quality of life will be measured using the Short Form Health Survey (SF-36)

    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.

    Time frame: Week 3 - 6 (once), Week 15-18 (once), week 27-30 (once)

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Malik RN, Sobeeh MG, Maharaj AL, Shackleton C, Hosseinzadeh A, Saloojee M, Khavandegar A, Kontaxakis A, Thordarson T, Chang C, Balthazaar SJT, Williams AMM, Lam T, Ghuman A, Anderson K, Elliott SL, Berger MJ, Samejima S, Sachdeva R, Krassioukov AV. Moving from mechanisms to clinical practice: non-invasive spinal cord stimulation for recovery of autonomic functions after spinal cord injury - a protocol for a pilot randomised controlled trial. BMJ Open. 2026 May 27;16(5):e119795. doi: 10.1136/bmjopen-2026-119795. PubMed 42203266 ↗
  • Malik RN, Samejima S, Williams AMM, Hosseinzadeh A, Ogalo E, Stolz A, Lam C, Shackleton C, Miller T, Sobeeh MG, Boyd LA, Kramer JLK, Lam T, Sachdeva R, Berger MJ, Krassioukov AV. Non-invasive spinal cord neuromodulation enables volitional anti-gravity leg movements after motor-complete spinal cord injury: responders vs. non-responders. J Neuroeng Rehabil. 2026 May 18;23(1):216. doi: 10.1186/s12984-026-02011-9. PubMed 42152086 ↗

Individual participant data

Plan to share: Yes — The research team plans to deposit final de-identified research data at a community-based repository for SCI research, such as Open Data Commons for SCI (https://odc-sci.org//). Research resources, including but not limited to, established stimulation parameter and recording equipment, will also be made available through material transfer agreement upon reasonable request.

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: Data will be available upon full-text print publication in a peer-reviewed journal, for a duration of at least 10 years.

Access criteria: Online access or e-mail request to the corresponding author from an established scientific investigator

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Oct 2026, 36 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 21, 2022
First posted
May 11, 2022
StartActual
Oct 3, 2023
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2027
Last update
Dec 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05369520
Collaborators
United States Department of Defense, Congressionally Directed Medical Research Programs
Responsible party
Andrei Krassioukov (Professor, University of British Columbia) — Principal investigator
First posted
May 11, 2022
Start date
Oct 3, 2023
Primary completion
Oct 2026 (estimated)
Completion
Oct 2027 (estimated)
Last update
Dec 8, 2025

Study contacts

Andrea L. Maharaj, BSc
Contact
AMaharaj@icord.org
604-675-8856
Soshi Samejima, PhD
Contact
soshi@icord.org
604 675 8816
Andrei Krassioukov, MD, PhD, FRCPC
principal investigator · The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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