Spinal Cord and Artificial Intelligence
- Conditions
- Spinal Cord Injuries
- Interventions
- Device: Biomedical equipment (Eclipse Nim, Medtronic®)
- Registration Number
- NCT02833428
- Lead Sponsor
- Fondation Hôpital Saint-Joseph
- Brief Summary
The aim of this study was to analyze using an artificial intelligence engine (IA) the influence of the pathophysiological environment (set parametric monitoring data, imaging, biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish the principles of a new approach for studying spinal cord injury patients. It does not meet the usual criteria of clinical trials in so far as it does not test on patients the effect of a therapeutic
- Detailed Description
Objectives
The objectives are multiple:
1. Analyze clinical situation in the pathophysiology of spinal pain.
2. somatosensory evoked potentials analysis (PES) and motors (PEM) on injuries of the spinal cord in the acute phase.
3. Increasing the mass of data integrated from current standards (volume). The reason is not only an imperative of statistical power as in a conventional test but the probability of specific events characterize this type of pathology and the consequences of their management (monitoring and therapeutic).
4. Identify new predictive parameters and monitoring of spinal pain.
5. Design the tools of computer collection, successful storage formats, adaptations of collection tools: This is validation of the technical solution (i.e. IA).
Expected results
This system will allow to record and analyze a large amount of parameters, largely beyond the human resources. Analysis of these data should allow better understanding of the pathophysiology of acute trauma of the spinal cord which is an essential prerequisite to research new therapies. The realization evoked potentials, ever conducted on this patient in the acute phase should also allow the investigators to better understand the mechanisms of evolution of the SCI (Spinal Cord Injury).
Moreover, this model expert system must allow, through the creation of routines, discovering new predictive parameters and monitoring, improving the management of these patients.
This is a completely open system that can be enriched with new parameters as and above all enriching also as and when the inclusion of new cases. It therefore offers a theoretical field of infinite discovery extremely promising.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1
- Patient with acute spinal cord injury between the cord opposite the vertebra C2 and marrow compared to the T12 vertebra.
- neurological lesion classified A, B, C or D according to Frankel classification at the initial examination (Annex 1).
- Patient able to give informed consent
There are no exclusion criteria. All patients meeting the inclusion criteria are includable. However, it differs remarkable different situations:
- The clinical neurological assessment of patients may be difficult depending on the context: intubated patients admitted - ventilated multiple trauma.
- Neurological assessment via evoked potentials may be difficult depending on the environment for patient care: need for multiple investigations, resuscitation. Evoked potentials will be installed only after agreement of the healthcare team once the patient is stabilized.
- The patient can refuse to submit to one additional exam is not part of the standard care (i.e. PES / PEM); it will be offered to participate in the study without the completion of this review. It will be in this case a simple use of clinical and laboratory data collected retrospectively anonymized so for scientific purposes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description patients with acute spinal cord injury Biomedical equipment (Eclipse Nim, Medtronic®) The study will be performed on patients with acute spinal cord injury between the cord next to the C2 vertebra and marrow next to the T12 vertebra. This is usually hospitalized patients in an emergency situation, brought by EMS (emergency medical services) and taken care of immediately in the recovery room by intensivists. Patients who accepted to participate to this study will got the installation bedside biomedical equipment for the project (Eclipse Nim, Medtronic®). The aim of this work is to analyze using an artificial intelligence engine (IA, Biomedical equipment (Eclipse Nim, Medtronic®)) the influence of the physiopathological environment (set of parametric data monitoring, imaging, biology etc.) of the traumatized spinal cord on spinal pain.
- Primary Outcome Measures
Name Time Method Assessment of change of ASIA impairment scale (American Spinal Cord Injury Association) Day1, 6 months and 1 year ASIA impairment scale allows to classify the spinal cord injury according to its level of neurological damage. It is conventionally represented by the most caudal segment having a normal function.
It allows to appreciate the completeness or incompleteness of the attack. It allows a classification highlighting the severity of the attack by using a five-letter ASIA anomaly scale from A to E.
- Secondary Outcome Measures
Name Time Method Assessment of change of Motor Evoked Potentials (PEM) Day1, 6 months The principal investigator proceeds to the installation of the patient's biomedical material for the project (Nim Eclipse, Medtronic®). The duration of the monitoring will be function the duration of hospitalization in SSPI Gaston Cordier and will not exceed 72 hours. Each night during this period, a non-stimulation range of 6 hours will be provided to allow the included volunteers to sleep.
Assessment of change of Somatosensory Evoked Potentials (SEPs) Day1, 6 months The principal investigator proceeds to the installation of the patient's biomedical material for the project (Nim Eclipse, Medtronic®). The duration of the monitoring will be function the duration of hospitalization in SSPI Gaston Cordier and will not exceed 72 hours. Each night during this period, a non-stimulation range of 6 hours will be provided to allow the included volunteers to sleep.
Trial Locations
- Locations (1)
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, Ile-de-France, France