Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:40 PM
Ignite Modification Date:
2025-12-24 @ 1:40 PM
NCT ID:
NCT04316195
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:
NCT04316195
Study Brief:
Protocol Section:
NCT04316195