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

  • STATUS
    Recruiting
  • End date
    Aug 26, 2022
  • participants needed
    20
  • sponsor
    Hospices Civils de Lyon
Updated on 26 January 2021

Summary

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.

Details
Condition HEAD INJURY, Subarachnoid Hemorrhage, Brain Lesions, Brain Lesion, Cerebral Lesion, head trauma, craniocerebral injury
Treatment Electrode implantation
Clinical Study IdentifierNCT04585503
SponsorHospices Civils de Lyon
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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