Recruiting

TCSCS

Sponsor:

University of British Columbia

Code:

NCT05369520

Conditions

Spinal Cord Injury

Autonomic Dysfunction

Sexual Dysfunction

Neurogenic Bladder Dysfunction

Neurogenic Bowel Dysfunction

Eligibility Criteria

Sex: All

Age: 19 - 60

Healthy Volunteers: Not accepted

Interventions

TESCoN or SCONE device - Thoracic stimulation

TESCoN or SCONE device - Lumbosacral stimulation

Study Details

Brief 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).

Conditions

Spinal Cord Injury

Autonomic Dysfunction

Sexual Dysfunction

Neurogenic Bladder Dysfunction

Neurogenic Bowel Dysfunction

Study ID

NCT05369520

Start date

Oct 3, 2023

Status verified date

Nov, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 60

Healthy Volunteers: Not accepted

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 childbearing potential, 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 contraception, 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 informed consent.
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:

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. Clinically significant, 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 investigational 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 - Thoracic stimulation

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

experimental: Group 2- Lumbosacral stimulation

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

Interventions

TESCoN 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.

TESCoN 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.

Primary outcome measure

  • Targeted TCSCS map modulate resting blood pressure (BP) [ Time Frame: Week 1-2 (once) ]
  • Targeted TCSCS map to activate skeletal muscles and pelvic floor muscles [ Time Frame: Week 1-2 (once) ]
  • Immediate change in BP during the head up tilt test (HUTT) [ Time Frame: Week 3 - 6 (once) ]
  • Change in BP during the head up tilt test (HUTT) from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in BP during the head up tilt test (HUTT) from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Immediate change in BP during digital anorectal stimulation (DARS) [ Time Frame: Week 3 - 6 (once) ]
  • Change in BP during digital anorectal stimulation (DARS) from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in BP during digital anorectal stimulation (DARS) from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Immediate change in rectal pressure measured by anorectal manometry (ARM) [ Time Frame: Week 3 - 6 (once) ]
  • Immediate change in high pressure anal canal zone measured by ARM [ Time Frame: Week 3 - 6 (once) ]
  • Immediate change in recto-anal inhibitory reflex measured by ARM [ Time Frame: Week 3 - 6 (once) ]
  • Immediate change in rectal sensation measured by ARM [ Time Frame: Week 3 - 6 (once) ]
  • Change in rectal pressure measured by ARM from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in high pressure anal canal zone measured by ARM from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in rectal sensation measured by ARM from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in recto-anal inhibitory reflex measured by ARM from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in rectal pressure measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Change in high pressure anal canal zone measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Change in recto-anal inhibitory reflex measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Change in rectal sensation measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Immediate change in intravesical pressure at first sensation measured by urodynamic investigation (UDI) [ Time Frame: Week 3 - 6 (once) ]
  • Immediate change in intravesical pressure at leakage point measured by UDI [ Time Frame: Week 3 - 6 (once) ]
  • Immediate change in intravesical pressure at maximal volume measured by UDI [ Time Frame: Week 3 - 6 (once) ]
  • Change in intravesical pressure at first sensation measured by UDI from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in intravesical pressure at leakage point measured by UDI from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in intravesical pressure at maximal volume measured by UDI from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in intravesical pressure at first sensation measured by UDI from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Change in intravesical pressure at leakage point measured by UDI from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Change in intravesical pressure at maximal volume measured by UDI from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Immediate change in BP during penile or clitoral vibrostimulation [ Time Frame: Week 3 - 6 (once) ]
  • Change in BP during penile or clitoral vibrostimulation from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in BP during penile or clitoral vibrostimulation from baseline to 8 weeks after cessation of TCSCS [ Time Frame: Week 27-30 (once) ]
  • Baseline assessment of colonic motility using the wireless motility capsule [ Time Frame: Week 3 - 6 (once) ]
  • Change in colonic motility using the wireless motility capsule from baseline to after completion of 8 weeks of TCSCS [ Time Frame: Week 15-18 (once) ]
  • Change in colonic motility using the wireless motility capsule from baseline to 8 weeks after TCSCS cessation. [ Time Frame: Week 27-30 (once) ]

Central Contacts and Locations

Central contacts

Andrea L. Maharaj, BSc

604-675-8856AMaharaj@icord.org

Soshi Samejima, PhD

604 675 8816soshi@icord.org

Locations

Blusson Spinal Cord Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Andrea Maharaj, BSc

6046758856amaharaj@icord.org

Principal Investigator:

Andrei Krassioukov, MD,PhD,FRCPC

St Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Amandeep Ghuman, MD,MPH,FRCSC

604-806-8860jennifer.phan@vch.ca

More Information

Sponsor

University of British Columbia

Last update posted

Dec 8, 2025

Last verified

Nov, 2025

Keywords

  • Neurostimulation
  • Spinal Cord Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-12-08.