Evaluation of the Bulbocavernosus Reflex After Acute Spinal Cord Injury
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| ClinicalTrials.gov Identifier: NCT04316195 |
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Recruitment Status : Unknown
Verified March 2020 by Andréane Richard-Denis, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal.
Recruitment status was: Enrolling by invitation
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Bulbocavernosus Reflex Spinal Cord Injuries | Diagnostic Test: Assessment of the bulbocavernosus reflex |
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 [Patient Registry] |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Months |
| Official Title: | Electromyographic Evaluation of the Bulbocavernosus Reflex After Acute Spinal Cord Injury: a New Prognostic Concept |
| Estimated Study Start Date : | August 1, 2020 |
| Estimated Primary Completion Date : | August 31, 2021 |
| Estimated Study Completion Date : | August 31, 2021 |
| 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. |
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316195
| Canada, Quebec | |
| CIUSSS du Nord-de-l'île-de-Montréal-Hôpital du Sacré-Cœur de Montréal | |
| Montréal, Quebec, Canada, H4J 1C5 | |
| Principal Investigator: | Andréane Richard-Denis, M.D., MSC. | CIUSSS du Nord-de-l'Île-de-Montréal-Hôpital du Sacré-Cœur de Montréal |
| Responsible Party: | Andréane Richard-Denis, MD. MSc. Physiatrist in Physical Medicine and Rehabilitation following spinal cord injury, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal |
| ClinicalTrials.gov Identifier: | NCT04316195 |
| Other Study ID Numbers: |
2019-1709 |
| First Posted: | March 20, 2020 Key Record Dates |
| Last Update Posted: | March 20, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Bulbocavernosus reflex following a traumatic spinal cord injury |
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Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |