Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury (NCT06333886)
Using a Point-of-care Electrophysiological Method to Study the Impact of Neuro-sacral Function on Recovery After Acute Spinal Cord Injuries
🩺 Plain-English Summary (8th-Grade Level)
Assessing the sacral nerves is an integral aspect of the evaluation after a spinal cord injury. Being located at the lower end of the spinal cord, the sacral nerves reflect how signals travel through the injured spinal cord. Sacral assessment is therefore essential to determine the level and severity of the spinal cord injury, which helps selecting the proper treatment and predicting recovery (worse when abnormal sacral function. The current assessment relies solely on a manual evaluation, which depends heavily on the physician's experience and does not provide any quantitative value of the dysfunction. The lack of a quantitative method adapted to the clinical setting is a major barrier limiting our knowledge on the impact of sacral function on recovery. We have recently developed an electrophysiological method providing quantitative sacral assessment at bedside after spinal cord injuries. Using this method, we will quantify sacral function in 250 patients with acute spinal cord injuries, and determine its association with recovery 6 months post-injury. We hypothesize that sacral function assessed early within the first 6 weeks after the injury with our method is associated with a better 6-month recovery of motor, sensory, bowel and bladder function. Our objectives are to assess the changes is sacral function during the first 6 months after the injury, and the relationship between early sacral function and 6-month recovery. Sacral function and recovery will be assessed up to 6 months post-injury by the attending physician, in order to measure the electromyographic magnitude of voluntary anal contraction, electromyographic magnitude of anal contraction elicited through sacral reflex testing, and minimal electrical stimulation for which anal sensation is present. The analysis will determine if and how sacral function evolves in time, and if there are specific quantitative criteria of sacral function that physicians can use to determine if patient will have a favorable recovery.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (13 items).
Location: Hôpital du Sacré-Coeur de Montréal — Montreal, Quebec
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Injury not due to blunt trauma or tumour
- Assessment of neuro-sacral function cannot be performed postoperatively within 1 week on the injury (e.g. due to cognitive or brain disorder, sedation, etc.)
- Expected survival less than 6 months
- No spinal surgery performed
- Subacute or chronic spinal cord or cauda equina injury at spinal surgery (delay \> 5 days between onset of neurological symptoms and surgery)
- Incomplete or aborted surgical decompression of spinal cord or cauda equina
- Complete spinal cord transection confirmed from preoperative MRI and/or during surgery
- Moderate or severe brain injury (mild traumatic brain injury not an exclusion criteria)
- Associated or preexisting anorectal or pelvic pathology
- Pre-existing neurological disorders such as cerebrovascular disease, Parkinson's disease, multiple sclerosis, stroke, etc.
- Limitation (e.g. in prision, living in another country, unwilling to comply with follow-up visits) to attend follow-up visits up to 6 months after the injury
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Hôpital du Sacré-Coeur de Montréal — Montreal, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Spinal Cord Injuries clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.