Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06333886
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-20
Brief Title:
Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury
Sponsor:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de lile de Montreal
Organization:
Centre Integre Universitaire de Sante et Services Sociaux du Nord de lile de Montreal
Study Overview
Official Title:
Using a Point-of-care Electrophysiological Method to Study the Impact of Neuro-sacral Function on Recovery After Acute Spinal Cord Injuries
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 physicians 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
Detailed Description:
BACKGROUND Following spinal cord and cauda equina injuries clinicians perform a neuro-sacral assessment to establish the injury severity select proper treatment and rehabilitation needs neuro-sacral dysfunction is an indication for surgery and requires rehabilitation in a specialized facility and predict recovery Current assessments rely on a qualitative digital rectal evaluation which lacks sensitivity and depends heavily on the clinicians experience Our previous findings suggest that assessing acute neuro-sacral function within the first days post-injury provides important insights on motor sensory and bowelbladder recovery However the lack of an accessible quantitative evaluation method adapted to the clinical setting is a major barrier limiting our knowledge on neuro-sacral function hampering the improvement in care management We have recently validated an quantitative electrophysiological method to assess neuro-sacral function at bedside that preserves the key assessments of the manual evaluation anal contractionsensation and sacral reflexes and eliminates the need to insert the finger into the rectum while being more sensitive to detect changes in neuro-sacral function
GOALS We believe that using a quantitative evaluation method is an essential step for optimizing the neurological assessment by clinicians and for underpinning the impact of early neuro-sacral function on long-term recovery We therefore hypothesize that acute neuro-sacral function is associated with motor sensory and bowelbladder recovery 6 months post-injury
The specific aims are
1 Assess longitudinal neuro-sacral function for 6 months post-injury
2 Assess the relationship between neuro-sacral function and neurofunctional recovery in order to identify clinical phenotypes of neuro-sacral function and quantitative thresholds associated with improved recovery
METHODS For this 4-year longitudinal study neuro-sacral function and recovery will be assessed in 450 individuals 1 2 6 weeks and 6 months after an acute spinal cord and cauda equina injuries Neuro-sacral assessments will be performed by the attending physiatrist to measure the 1 electromyographic signal amplitude of voluntary anal contraction 2 electromyographic signal amplitude of anal contraction elicited through anal reflex testing and 3 perianal electrical perceptual threshold Study endpoints 6 months post-injury include the improvement in neurological status primary endpoint 10-point improvement in motor score and bowelbladder function Longitudinal changes in neuro-sacral function will be characterized from ANOVA Classification and regression tree analysis will be used to identify clinical phenotypes and objective quantitative thresholds
EXPECTED OUTCOMES By implementing an accessible point-of-care quantitative method to assess neuro-sacral function in the clinical setting we have a real potential to transform the care standards for spinal cord and cauda equina injuries and improve the efficiency and accuracy for identifying of neuro-sacral dysfunction We will improve our understanding of the early changes in neuro-sacral dysfunction therefore bringing new knowledge on the predictors of recovery We will identify 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
GOALS We believe that using a quantitative evaluation method is an essential step for optimizing the neurological assessment by clinicians and for underpinning the impact of early neuro-sacral function on long-term recovery We therefore hypothesize that acute neuro-sacral function is associated with motor sensory and bowelbladder recovery 6 months post-injury
The specific aims are
1 Assess longitudinal neuro-sacral function for 6 months post-injury
2 Assess the relationship between neuro-sacral function and neurofunctional recovery in order to identify clinical phenotypes of neuro-sacral function and quantitative thresholds associated with improved recovery
METHODS For this 4-year longitudinal study neuro-sacral function and recovery will be assessed in 450 individuals 1 2 6 weeks and 6 months after an acute spinal cord and cauda equina injuries Neuro-sacral assessments will be performed by the attending physiatrist to measure the 1 electromyographic signal amplitude of voluntary anal contraction 2 electromyographic signal amplitude of anal contraction elicited through anal reflex testing and 3 perianal electrical perceptual threshold Study endpoints 6 months post-injury include the improvement in neurological status primary endpoint 10-point improvement in motor score and bowelbladder function Longitudinal changes in neuro-sacral function will be characterized from ANOVA Classification and regression tree analysis will be used to identify clinical phenotypes and objective quantitative thresholds
EXPECTED OUTCOMES By implementing an accessible point-of-care quantitative method to assess neuro-sacral function in the clinical setting we have a real potential to transform the care standards for spinal cord and cauda equina injuries and improve the efficiency and accuracy for identifying of neuro-sacral dysfunction We will improve our understanding of the early changes in neuro-sacral dysfunction therefore bringing new knowledge on the predictors of recovery We will identify 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None