Non-invasive spinal cord stimulation to restore autonomic function after spinal cord injury

Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice

This trial tests whether transcutaneous spinal cord stimulation can help adults with chronic spinal cord injury improve blood pressure control, bladder, bowel, or sexual problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 19 Years to 60 Years
• Sex: All
• Sponsor: University of British Columbia (Academic / other)
• Locations: 2 sites (Vancouver, British Columbia and 1 other locations)
• Trial ID: NCT05369520 on ClinicalTrials.gov

What this trial studies

This pilot study will recruit 30 adults with chronic traumatic spinal cord injury and autonomic dysfunction to receive transcutaneous spinal cord stimulation (TCSCS). After screening and spatiotemporal mapping of relevant spinal segments, participants will complete baseline functional assessments with and without stimulation and then be randomized to 8 weeks of TCSCS delivered to either mid/low thoracic or lumbosacral levels (three sessions per week). Functional outcomes for blood pressure regulation, lower urinary tract, bowel, and sexual function will be measured before and after the intervention across multiple visits at ICORD/Blusson Spinal Cord Centre and St Paul's Hospital, with anorectal manometry performed at the GI clinic. The protocol uses randomized orderings and counter-balanced pathways to reduce order effects and compare stimulation targets.

Who should consider this trial

Good fit: Adults 19–60 who live in British Columbia with chronic traumatic SCI at or above T6, AIS grade A or B, more than one year post-injury, clinically stable, and experiencing bladder, bowel, or sexual dysfunction are ideal candidates.

Not a fit: People with progressive neurological disease, injuries below T6, recent spinal surgery, active infections or unhealed wounds, pregnant or breastfeeding women, or those without autonomic symptoms are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the intervention could improve blood pressure control and bladder, bowel, or sexual function, improving daily health and quality of life for people with spinal cord injury.

How similar studies have performed: Small prior studies and case reports of non-invasive spinal stimulation have shown promising improvements in autonomic and motor functions, but larger randomized trials are still lacking.

Eligibility criteria

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.

Where this trial is running

Vancouver, British Columbia and 1 other locations

• Blusson Spinal Cord Centre — Vancouver, British Columbia, Canada (Recruiting)
• St Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Andrei Krassioukov, MD, PhD, FRCPC — The University of British Columbia, International Collaboration on Repair Discoveries (ICORD)
• Study coordinator: Andrea L. Maharaj, BSc

Conditions Spinal Cord Injury; Autonomic Dysfunction; Sexual Dysfunction; Neurogenic Bladder Dysfunction; Neurogenic Bowel Dysfunction; Autonomic Dysreflexia; Orthostatic Hypotension; Neurostimulation