NCT02833428

Spinal Cord and Artificial Intelligence

Acquisition and Analysis of Medullary Trauma Patients Signs, With an Expert Model

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Fondation Hôpital Saint-Joseph · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Biomedical equipment (Eclipse Nim, Medtronic®)	It is the principal investigator (coordinator investigator moving on the website of the Pitié-Salpêtrière) that will install bedside biomedical equipment for the project (Eclipse Nim, Medtronic®) The term of monitoring will depend of length of stay in the PACU (the post anesthesia care unit) Gaston Cordier and will not exceed 72 hours. • Patients will be reviewed at 6 and 12 months for conventional control with establishing a ASIA score (American Spinal Cord Injury Association). Of SEP (Somatosensory evoked potentials) and MEP(Motor Engine Potentials) will be performed in the laboratory at 6 and 12 months (electrophysiology laboratory Pitié-Salpêtrière). They are part of the traditional support in the context of spinal cord trauma.

Timeline

• Start date: 2018-01-20
• Primary completion: 2022-01-20
• Completion: 2023-12-20
• First posted: 2016-07-14
• Last updated: 2023-03-07

Locations

1 site across 1 country: France