Clinical trial NCT04585503: Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.
Official title: Feasibility Study of Cortical Recording Depolarizations in Brain-injured Patients, and Their Use as Biomarkers of New Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Lesion
Head Trauma
Subarachnoid Hemorrhage
Keywords: subdural or intra cortical implanted electrodes
CNS monitor
brain lesions
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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,

Primary outcomes:
measure: Evaluation of Invasive cortical depolarization (SD) recorded in a non-expert center with subdural or intra cortical implanted electrode and central nervous system monitoring.
timeFrame: 18 months
Secondary outcomes:
measure: Evaluation of electrode implantation safety
timeFrame: during implantation procedure
measure: Evaluation of electrode implantation safety
timeFrame: during monitoring, maximum 15 days
measure: Evaluation of electrode implantation safety.
timeFrame: during electrode extraction
measure: Evaluation of temporality between Invasive cortical depolarization and intracranial hypertension.
timeFrame: during monitoring, maximum 15 days
measure: Evaluation of temporality between Invasive cortical depolarization and oxygen in tissue decreasing pressure
timeFrame: during monitoring, maximum 15 days
measure: Evaluation of temporality between Invasive cortical depolarization and detection of a vasospasm
timeFrame: during monitoring, maximum 15 days
measure: Evaluation of temporality between Invasive cortical depolarizations and EEG change of rhythm.
timeFrame: during monitoring, maximum 15 days
measure: Evaluation of temporality between Invasive cortical depolarization and detection of a new cerebral lesion.
timeFrame: during monitoring, maximum 15 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer
Study officials:
References: