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

Civil Hospices of Lyon

Status: Completed

Conditions: Subarachnoid Hemorrhage; Head Trauma; Brain Lesion

Treatments: Device: Electrode implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT04585503

69HCL19_0615

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Central nervous system monitoring

Experimental group

Description:

Each 20 patients will be implanted with subdural or intra cortical electrodes

Treatment:

Device: Electrode implantation