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Use of Point-of-care Neuro-sacral Electrophysiology Following Spinal Cord Injury

NCT06333886 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2024-03-27

No results posted yet for this 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.

Conditions

  • Spinal Cord Injuries
  • Neurogenic Bowel
  • Neurogenic Bladder Dysfunction

Interventions

DEVICE

Sacral electromyography

Assessment of neuro-sacral function using point-of-care sacral surface electromyography

Sponsors & Collaborators

  • Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-18
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06333886 on ClinicalTrials.gov