Spinal stimulation offers new hope for autonomic recovery after injury
NCT ID NCT05369520
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a non-invasive spinal cord stimulation device can improve autonomic functions like blood pressure, bladder, bowel, and sexual control in people with chronic spinal cord injury. Thirty participants will receive targeted stimulation over several weeks. The goal is to see if this approach can safely ease common complications and improve quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2023
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Blusson Spinal Cord Centre
RECRUITINGVancouver, British Columbia, V5Z 1M9, Canada
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St Paul's Hospital
RECRUITINGVancouver, British Columbia, V6Z 1Y6, Canada
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