Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1 participants
INTERVENTIONAL
2018-01-20
2023-12-20
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* neurological lesion classified A, B, C or D according to Frankel classification at the initial examination (Annex 1).
* Patient able to give informed consent
* 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.
18 Years
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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RIOUALLON Guillaume, MD
Role: PRINCIPAL_INVESTIGATOR
Groupe Hospitalier Paris Saint-Joseph (FRANCE)
Locations
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Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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SKY
Identifier Type: -
Identifier Source: org_study_id
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