Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury
Key facts
- Who runs it
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 450 people, planned
- Started
- 18 Mar 2024
- Expected to end
- 31 Dec 2028
- Type of study
- Observational
- Treatments tested
- Sacral electromyography
- Record updated
- 27 March 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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.)
- Pre-existing neurological disorders such as cerebrovascular disease, Parkinson's disease, multiple sclerosis, stroke, etc
- Injury not due to blunt trauma or tumour
- Expected survival less than 6 months
- Moderate or severe brain injury (mild traumatic brain injury not an exclusion criteria)
- Associated or preexisting anorectal or pelvic pathology
- 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
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The group in the trial
- SCI patients with neuro-sacral dysfunction
450 patients with traumatic and non-traumatic acute SCI admitted to a level-1 trauma hospital in Montreal, Quebec, Canada
Treatment: Sacral electromyography
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Using a Point-of-care Electrophysiological Method to Study the Impact of Neuro-sacral Function on Recovery After Acute Spinal Cord Injuries
- Record updated
- 27 March 2024