Evaluation of the Bulbocavernosus Reflex After Acute Spinal Cord Injury

March 18, 2020 updated by: Andréane Richard-Denis

Electromyographic Evaluation of the Bulbocavernosus Reflex After Acute Spinal Cord Injury: a New Prognostic Concept

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H4J 1C5
        • CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient admitted to the Hôpital du Sacré-Coeur de Montréal for a traumatic spinal injury.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient admitted for an acute traumatic spinal cord injury
Diagnostic test: Assessment of the bulbocavernosus reflex

According to the International Standards for Neurological Classification of Spinal Cord : The standard examination consists of the contraction of the bulbocavernous muscle following stimulation of the glans of the penis in men and of the clitoris in women.

By electromyography: The electromyography consists to stimulate the bulbocavernosus reflex with a bipolar probe apply on the glans for men, and on the clitoris in women. A surface electrode will be positioned on the right or left bulbocavernous muscle at the base of the penis (or vagina) and the anus for recording. The bulbocavernous reflex will be obtained by stimulation at a frequency of 1.5Hz and an amplitude of 14 to 47 mA.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andréane Richard-Denis

Investigators

  • Principal Investigator: Andréane Richard-Denis, M.D., MSC., CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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