Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.

Hospices Civils de Lyon20 enrolled

Overview

The progression of brain lesions after severe head trauma or subarachnoid hemorrhage results from extra cranial aggression which is well controlled in intensive care and intracranial aggression which is less well known and therefore less well managed. The detection of events that can generate new lesions from intracranial monitoring is limited and late once the lesions are irreversible. Invasive cortical depolarizations (SD) can be observed using cortical electrodes and an acquisition system having access to the usually filtered DC signal (0 to 1 Hz). SD are observed at the onset of a new attack of the cortex and spread widely away from the site of aggression. During their propagation, SD generate a significant metabolic demand, and can cause ischemic injury, particularly after meningeal or post-traumatic hemorrhage. SDs are therefore both a marker of new lesion and a mechanism of progression of primary lesions. Yet this type of monitoring is only performed in some expert centers around the world. The analysis of the feasibility and safety of the placement of cortical electrodes in this indication is therefore an essential step to study the clinical benefit of individualized management on the basis of this monitoring.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Brain Lesion Head Trauma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient \> 18 year old * Patients admitted in neurological reanimation unit for brain lesions after severe head trauma or subarachnoid hemorrhage and requesting a intracranial monitoring or a surgery (evacuation of a hematoma, treatment of an aneurysm, external ventricular bypass). * Patients affiliated to a social security system * Patient having been informed and having signed the Consent form OR Close to the patient who has been informed and signed the Consent form OR third party certificate then close consent for further study. Exclusion Criteria: * Patient with scalp acute infection * Pregnant or nursing women * Contre-indication to intracranial surgery * Patient with not corrected coagulation disorder * Patient treated with NSAIDS * Patient treated with under platelet antiaggregants * Patient under legal protection, guardianship, curators * patients under legal protection * Patient participating in a study who may interfere with this study. * people under duress psychiatric care,

Outcomes

Primary Outcomes

Evaluation of Invasive cortical depolarization (SD) recorded in a non-expert center with subdural or intra cortical implanted electrode and central nervous system monitoring.

The feasibility of the study will be objectivized by the availability of a signal of sufficient quality to be exploited, with or without SD: namely a signal without artifact on more than 30% of the recording period on at least 3 electrodes on 6 for at least 12h. The signal analysis should, at least twice a day, allow intervening with the patient if necessary.

Time frame: 18 months

Secondary Outcomes

Evaluation of electrode implantation safety

Safety will be evaluated recording severe and non-severe adverse events during implantation procedure.

Time frame: during implantation procedure

Evaluation of electrode implantation safety

Safety will be evaluated recording severe and non-severe adverse events during monitoring