Spinal Cord and Artificial Intelligence (SKY)
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|ClinicalTrials.gov Identifier: NCT02833428|
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : May 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Biomedical equipment (Eclipse Nim, Medtronic®)||Not Applicable|
The objectives are multiple:
- Analyze clinical situation in the pathophysiology of spinal pain.
- somatosensory evoked potentials analysis (PES) and motors (PEM) on injuries of the spinal cord in the acute phase.
- 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).
- 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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acquisition and Analysis of Medullary Trauma Patients Signs, With an Expert Model|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||January 20, 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: patients with acute spinal cord injury
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.
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.
- Assessment of change of ASIA impairment scale (American Spinal Cord Injury Association) [ Time Frame: 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.
- Assessment of change of Somatosensory Evoked Potentials (SEPs) [ Time Frame: 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 Motor Evoked Potentials (PEM) [ Time Frame: 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.
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): NCT02833428
|Contact: RIOUALLON Guillaume, MD||+33 1 44 12 74 firstname.lastname@example.org|
|Contact: Pascal-Moussellard Hugues, PharmD, PhD||+33 1 42 17 70 51||Hugues.email@example.com|
|Groupe Hospitalier Paris Saint Joseph||Recruiting|
|Paris, Ile-de-France, France, 75014|
|Contact: BEAUSSIER Helene, PhD, PharmD +33 1 44 12 70 38 firstname.lastname@example.org|
|Contact: CRC +33 1 44 12 70 33 email@example.com|
|Principal Investigator:||RIOUALLON Guillaume, MD||Groupe Hospitalier Paris Saint-Joseph (FRANCE)|