Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury (NCT06333886) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury
Canada450 participantsStarted 2024-03-18
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female aged \>/= 18 years
* Spinal cord injury (including cauda equina) due to trauma or extra-dural spinal tumour
* American Spinal Injury Association Impairment Scale grade A, B, C or D
* Neurological level of injury between C0 and S5
* Neurological examination performed prior to surgery according to the ISNCSCI\*
* Surgical treatment done at our institution within 5 days of onset of neurological symptoms
* Patient is willing and able to provide informed consent in English or French
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) …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Precise assessment and evaluation of neuro-sacral dysfunction
Timeframe: 4 years
Trial details
NCT IDNCT06333886
SponsorCentre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal