Sacral electromyography: Assessment of neuro-sacral function using point-of-care sacral surface electromyography
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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) to attend follow-up visits up to 6 months after the injury
* Major cognitive deficits precluding informed consent and/or assessments
Primary outcome measure(s)
Precise assessment and evaluation of neuro-sacral dysfunction — 4 years Improve the precision and accuracy for identifying of neuro-sacral dysfunction and improve understanding of the early changes in neuro-sacral dysfunction, bringing new knowledge on the predictors of recovery. Identification of clinical phenotypes of neuro-sacral function and propose objective threshold values to help clinicians identifying proper care trajectory and optimize resources use, using an accessible and validated method that is well tolerated by patients.
Trial sites (1)
Facility
City
Region
Status
Hôpital du Sacré-Coeur de Montréal
Montreal
Quebec
More Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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