Spinal Cord InjuryNCT05369520
Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury
A study testing TESCoN or SCONE device - Thoracic stimulation and TESCoN or SCONE device - Lumbosacral stimulation in people with Spinal Cord Injury and Autonomic Dysfunction, run by University of British Columbia at 2 sites in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Spinal Cord Injury, Autonomic Dysfunction, Sexual Dysfunction
- What is being tested?
- TESCoN or SCONE device - Thoracic stimulation and TESCoN or SCONE device - Lumbosacral stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 3 Oct 2023to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- American Spinal Injury Association Impairment Scale (AIS) A, B.
- Stable management of spinal cord related clinical issues (i.e., spasticity management).
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- Experience bladder, or bowel, or sexual dysfunction.
- No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
- For women of childbearing potential, not intending to become pregnant, currently pregnant, or lactating. The following conditions apply:
- 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.
- 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.
- If using combined hormonal contraception, a stable regimen during the period of the trial and for at least 28 days after completion of treatment.
- 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.
- Must provide informed consent.
- Willing and able to comply with all clinic visits and study-related procedures.
- 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).
Who cannot join
- 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.
- History of seizures/epilepsy or recurring headaches.
- Clinically significant, unmanaged, depression (to be screened) or ongoing drug abuse.
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- Intrathecal baclofen pump.
- Oral baclofen dose greater than 60mg.
- Individuals that have received intradetrusor or intrasphincter onabotulinumtoxinA injections within 6 months of baseline.
- Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
- Past electrode implantation surgery.
- Member of the investigational team or his/her immediate family.
- 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.
- Known allergies or sensitivities to both blue dye and beetroot powder.
- Known or suspected gastrointestinal obstruction.
- Persons with active inflammatory bowel disease or a history of bowel perforation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Blusson Spinal Cord Centre
Vancouver, British Columbia, V5Z 1M9
Andrea Maharaj, BSc, 6046758856, amaharaj@icord.org
Andrei Krassioukov, MD,PhD,FRCPC
- Recruiting
St Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Amandeep Ghuman, MD,MPH,FRCSC, 604-806-8860, jennifer.phan@vch.ca
About this study
Official title: Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice
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.
- Conditions
- Spinal Cord Injury, Autonomic Dysfunction, Sexual Dysfunction, Neurogenic Bladder Dysfunction, Neurogenic Bowel Dysfunction, Autonomic Dysreflexia
- Being tested
- TESCoN or SCONE device - Thoracic stimulation, TESCoN or SCONE device - Lumbosacral stimulation
- Keywords
- Neurostimulation, Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries, Primary Dysautonomias, Sexual Dysfunction, Physiological, Autonomic Dysreflexia, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TESCoN or SCONE device - Thoracic stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Thoracic stimulation | Experimental | Participants will receive 8 weeks TCSCS at the mid/low thoracic spinal cord levels. Receives: Device: TESCoN or SCONE device - Thoracic stimulation |
| Group 2- Lumbosacral stimulation | Experimental | Participants will receive 8 weeks TCSCS at the lumbosacral spinal cord levels. Receives: Device: TESCoN or SCONE device - Lumbosacral stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1-2 (once)
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.
Measured: Week 1-2 (once)
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.
Measured: Week 3 - 6 (once)
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.
Measured: Week 15-18 (once)
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.
Measured: Week 27-30 (once)
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.
Measured: Week 3 - 6 (once)
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.
Measured: Week 15-18 (once)
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.
Measured: Week 27-30 (once)
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).
Measured: Week 3 - 6 (once)
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).
Measured: Week 3 - 6 (once)
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.
Measured: Week 3 - 6 (once)
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).
Measured: Week 3 - 6 (once)
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).
Measured: Week 15-18 (once)
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).
Measured: Week 15-18 (once)
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).
Measured: Week 15-18 (once)
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.
Measured: Week 15-18 (once)
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).
Measured: 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
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing length of high pressure anal canal zone (cm).
Measured: Week 27-30 (once)
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.
Measured: Week 27-30 (once)
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).
Measured: Week 27-30 (once)
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).
Measured: Week 3 - 6 (once)
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).
Measured: Week 3 - 6 (once)
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).
Measured: Week 3 - 6 (once)
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).
Measured: Week 15-18 (once)
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).
Measured: Week 15-18 (once)
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).
Measured: Week 15-18 (once)
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).
Measured: Week 27-30 (once)
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).
Measured: Week 27-30 (once)
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).
Measured: Week 27-30 (once)
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.
Measured: Week 3 - 6 (once)
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.
Measured: Week 15-18 (once)
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.
Measured: Week 27-30 (once)
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.
Measured: Week 3 - 6 (once)
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.
Measured: Week 15-18 (once)
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.
Measured: Week 27-30 (once)
Secondary outcomes (9)
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.
Measured: Week 3 - 6 (once)
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.
Measured: Week 15-18 (once)
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.
Measured: Week 27-30 (once)
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.
Measured: Week 3 - 6 (once)
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.
Measured: Week 15-18 (once)
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.
Measured: Week 27-30 (once)
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.
Measured: Week 3 - 6 (once)
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.
Measured: Week 15-18 (once)
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.
Measured: Week 27-30 (once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start3 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a randomized counter-balanced approach, individuals will be allocated in two distinct pathways; the participants in Groups 1 (thoracic stimulation) and Group 2 (lumbosacral stimulation) will receive 8 weeks of TCSCS (3 times/week) at either mid/low thoracic or lumbosacral spinal cord levels respectively.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Andrei Krassioukov, University of British Columbia
- Investigators
- Andrei Krassioukov, MD, PhD, FRCPC, Principal investigator, The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369520
- Sponsor's protocol ID
- H22-00365
- Other IDs
- CDMRP-SC210078
- Status last verified
- Nov 2025
- First submitted
- 21 Mar 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
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 42203266Malik 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice
- ClinicalTrials.gov ID
- NCT05369520
- Acronym / sponsor ID
- H22-00365
- Conditions
- Spinal Cord Injury, Autonomic Dysfunction, Sexual Dysfunction, Neurogenic Bladder Dysfunction, Neurogenic Bowel Dysfunction, Autonomic Dysreflexia
- Keywords
- Neurostimulation, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a randomized counter-balanced approach, individuals will be allocated in two distinct pathways; the participants in Groups 1 (thoracic stimulation) and Group 2 (lumbosacral stimulation) will receive 8 weeks of TCSCS (3 times/week) at either mid/low thoracic or lumbosacral spinal cord levels respectively.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Thoracic stimulation | Experimental | Device: TESCoN or SCONE device - Thoracic stimulationParticipants will receive 8 weeks TCSCS at the mid/low thoracic spinal cord levels. |
| Group 2- Lumbosacral stimulation | Experimental | Device: TESCoN or SCONE device - Lumbosacral stimulationParticipants will receive 8 weeks TCSCS at the lumbosacral spinal cord levels. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
- American Spinal Injury Association Impairment Scale (AIS) A, B.
Key exclusion criteria (16 listed)
- 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.
- History of seizures/epilepsy or recurring headaches.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TESCoN or SCONE device - Thoracic stimulationTCSCS 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. | Device | Group 1 - Thoracic stimulation |
| TESCoN or SCONE device - Lumbosacral stimulationTCSCS 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. | Device | Group 2- Lumbosacral stimulation |
Primary outcome
Targeted TCSCS map modulate resting blood pressure (BP)
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.
Targeted TCSCS map to activate skeletal muscles and pelvic floor muscles
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.
Immediate change in BP during the head up tilt test (HUTT)
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.
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)
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.
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)
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.
Immediate change in BP during digital anorectal stimulation (DARS)
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.
Change in BP during digital anorectal stimulation (DARS) from baseline to after completion of 8 weeks of TCSCS
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.
Change in BP during digital anorectal stimulation (DARS) from baseline to 8 weeks after cessation of TCSCS
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.
Immediate change in rectal pressure measured by anorectal manometry (ARM)
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).
Immediate change in high pressure anal canal zone measured by ARM
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).
Immediate change in recto-anal inhibitory reflex measured by ARM
Time frame: Week 3 - 6 (once)
Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing recto-anal inhibitory reflex.
Immediate change in rectal sensation measured by ARM
Time frame: Week 3 - 6 (once)
Researchers will test the safety and efficacy of short-term TCSCS in reproducibly changing rectal sensation (mL).
Change in rectal pressure measured by ARM from baseline to after completion of 8 weeks of TCSCS
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).
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)
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).
Change in rectal sensation measured by ARM from baseline to after completion of 8 weeks of TCSCS
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).
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)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of long-term TCSCS in changing recto-anal inhibitory reflex.
Change in rectal pressure measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS
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).
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)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing length of high pressure anal canal zone (cm).
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)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing recto-anal inhibitory reflex.
Change in rectal sensation measured by anorectal manometry (ARM) from baseline to 8 weeks after cessation of TCSCS
Time frame: Week 27-30 (once)
Utilizing TCSCS and ARM, researchers will test the safety and efficacy of TCSCS in changing rectal sensation (mL).
Immediate change in intravesical pressure at first sensation measured by urodynamic investigation (UDI)
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).
Immediate change in intravesical pressure at leakage point measured by UDI
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).
Immediate change in intravesical pressure at maximal volume measured by UDI
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).
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)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of long-term TCSCS in changing intravesical pressure at first sensation (mmHg).
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)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of long-term TCSCS in changing intravesical pressure at leakage point (mmHg).
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)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of long-term TCSCS in changing intravesical pressure at maximal volume (mmHg).
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)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of TCSCS in changing intravesical pressure at first sensation (mmHg).
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)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of TCSCS in changing intravesical pressure at leakage point (mmHg).
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)
Utilizing TCSCS and UDI, researchers will test the safety and efficacy of TCSCS in changing intravesical pressure at maximal volume (mmHg).
Immediate change in BP during penile or clitoral vibrostimulation
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.
Change in BP during penile or clitoral vibrostimulation from baseline to after completion of 8 weeks of TCSCS
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.
Change in BP during penile or clitoral vibrostimulation from baseline to 8 weeks after cessation of TCSCS
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.
Baseline assessment of colonic motility using the wireless motility capsule
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.
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)
Utilizing TCSCS and the wireless motility capsule, researchers will test the safety and efficacy of long-term TCSCS in improving transit times.
Change in colonic motility using the wireless motility capsule from baseline to 8 weeks after TCSCS cessation.
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.
9 secondary outcomes
Immediate change in cerebral blood flow (CBF) measured by trans-cranial doppler (TCD) during HUTT
Time frame: Week 3 - 6 (once)
Change in CBF measured by TCD during HUTT from baseline to after completion of 8 weeks of TCSCS
Time frame: Week 15-18 (once)
Change in CBF measured by TCD during HUTT from baseline to 8 weeks after TCSCS cessation
Time frame: Week 27-30 (once)
Immediate change in performance on the verbal fluency test (VFT) during HUTT
Time frame: Week 3 - 6 (once)
Change in performance on the VFT from baseline to after completion of 8 weeks of TCSCS
Time frame: Week 15-18 (once)
Change in performance on the VFT from baseline to 8 weeks after TCSCS cessation
Time frame: Week 27-30 (once)
Immediate change in performance on the Stroop Color and Word (SCW) test during HUTT
Time frame: Week 3 - 6 (once)
Change in performance on SCW from baseline to after completion of 8 weeks of TCSCS
Time frame: Week 15-18 (once)
Change in performance on SCW from baseline to 8 weeks after TCSCS cessation
Time frame: Week 27-30 (once)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Derived from this study: PubMed 42203266Malik 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.
- Derived from this study: PubMed 42152086Malik 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrei Krassioukov, MD, PhD, FRCPC principal investigator
The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TESCoN or SCONE device - Thoracic stimulation and TESCoN or SCONE device - Lumbosacral stimulation in people with Spinal Cord Injury and Autonomic Dysfunction, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea L. Maharaj, BSc (604-675-8856, AMaharaj@icord.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted TCSCS map modulate resting blood pressure (BP) (time frame: Week 1-2 (once)). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369520, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.