Evaluation of the Bulbocavernosus Reflex After Acute Spinal Cord Injury

• Conditions: Bulbocavernosus Reflex; Spinal Cord Injuries
• Interventions: Diagnostic Test: Assessment of the bulbocavernosus reflex

• Registration Number: NCT04316195
• Lead Sponsor: Andréane Richard-Denis

Brief Summary

The purpose of this study is to evaluate the possibility to use electromyography in acute phase after a traumatic spinal cord injury to measure quantitatively and objectively the bulbocavernosus reflex. This study also aims to determine if there is a relationship between the bulbocavernosus reflex and neuro-functional recovery 3 months after a traumatic spinal cord injury. To do so, 20 patients admitted for acute traumatic spinal cord injury will be recruited prospectively. Within 72 hours post-trauma, the bulbocavernous reflex of all participants will be assessed according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and by electromyography. Neurological improvement during the rehabilitation process and functional status at 3 months following the traumatic spinal cord injury will also be assessed.

Detailed Description

Traumatic spinal cord injuries cause severe neurological deficits (motor, sensory and autonomic disorders). Affected individuals have functional limitations and a reduced quality of life that result in high medical and social costs. Some studies have shown that early rehabilitation improves recovery. It seems therefore essential to optimize patient management in the acute phase in order to improve interventions and optimize their functional recovery.

A major barrier to early patient management is associated with a lack of knowledge about the neurophysiological mechanisms of acute spinal cord injury. Moreover, early assessment of prognosis is still difficult to make. The early assessment is based almost exclusively on the clinical neurological examination and does not include an objective measurement of underlying neurophysiological processes. The possibility to establish an accurate neuro-functional prognosis at an early stage will have the advantage to guide clinical decision, allow the development of an appropriate rehabilitation plan and figure out the long-term needs of the patient while promoting better collaboration.

Clinical neurological examination includes among other things, the evaluation of the bulbocavernosus reflex. The purpose of this study is to evaluate the possibility to use electromyography in acute phase after a traumatic spinal cord injury to measure quantitatively and objectively the bulbocavernosus reflex. This study also aims to determine if there is a relationship between the bulbocavernous reflex and neuro-functional recovery 3 months after a traumatic spinal cord injury.

The bulbocavernous reflex of patients admitted for acute traumatic spinal cord injury will be assessed within 72 hours post-trauma according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and by electromyography. Neurological improvement during the rehabilitation process and functional status at 3 months following the traumatic spinal cord injury will also be assessed. Descriptive analyses will be proposed to characterize the bulbocavernous reflex obtained by electromyography evaluation. Comparative analyses will be carried out to describe the characteristics of patients with different bulbocavernosus reflex stimulation thresholds. Correlations will also be established to determine the relationship between the electromyography evaluation of the bulbocavernosus reflex and the neurological and functional improvement of the patient.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-18
• Last Update Submitted: 2020-03-18
• Study First Posted: 2020-03-20
• Last Update Posted: 2020-03-20
• Study Start: 2020-08-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• male or female age of 18 years or older
• patient with fracture, fracture-dislocation or vertebral dislocation from C0 to T12 inclusively
• patient with neurological impairment involving the motor spinal cord (severity AIS grade A or B) on initial assessment
• patient admitted to Hôpital du Sacré-Coeur de Montréal within 72 hours for trauma
• patient transfer to intensive functional rehabilitation

Exclusion Criteria

• pregnancy
• suspicion of sacral nerve damage (caused by trauma or other co-morbidities)
• spinal cord syndrome (caused by trauma or other comorbidities) or spinal cord signal abnormality on magnetic resonance imaging
• pre-existing major neurological impairment (e.g. stroke, Parkinson's disease, etc.)
• inability to consent (coma, delirium, etc.)
• perineal injury preventing the sacral EMG procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient admitted for an acute traumatic spinal cord injury	Assessment of the bulbocavernosus reflex	-

Primary Outcome Measures

Name	Time	Method
Characterize the bulbocavernosus reflex using electromyographic assessment within 72 hours of a traumatic spinal cord injury	During the acute care hospitalization, max 72 hours	Determine stimulation threshold, latency and amplitude of the signal
Determine the relationship between the bulbocavernosus reflex and the neurological and functional recovery of patients 3 months after a traumatic spinal cord injury	After hospitalization, 3 months post operation	Related neurological and functional improvement according to acute electromyographic reflex measurement

Trial Locations

Locations (1)

CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal; 🇨🇦 Montréal, Quebec, Canada