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

Not Applicable

Completed

• Conditions: Head Trauma; Subarachnoid Hemorrhage; Brain Lesion
• Interventions: Device: Electrode implantation

• Registration Number: NCT04585503
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Study Start: 2021-01-01
• Primary Completion: 2023-04-07
• Study Completion: 2023-04-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Central nervous system monitoring	Electrode implantation	Each 20 patients will be implanted with subdural or intra cortical electrodes

Primary Outcome Measures

Name	Time	Method
Evaluation of Invasive cortical depolarization (SD) recorded in a non-expert center with subdural or intra cortical implanted electrode and central nervous system monitoring.	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of temporality between Invasive cortical depolarization and detection of a vasospasm	during monitoring, maximum 15 days	proportion of patient with Invasive cortical depolarization before during and after detection of a vasospasm.
Evaluation of temporality between Invasive cortical depolarization and detection of a new cerebral lesion.	during monitoring, maximum 15 days	proportion of patient with Invasive cortical depolarization before, during and after detection of a new cerebral lesion.
Evaluation of temporality between Invasive cortical depolarization and oxygen in tissue decreasing pressure	during monitoring, maximum 15 days	proportion of patient with Invasive cortical depolarization before during and after oxygen in tissue decreasing.
Evaluation of electrode implantation safety	during monitoring, maximum 15 days	Safety will be evaluated recording severe and non-severe adverse events during monitoring
Evaluation of electrode implantation safety.	during electrode extraction	Safety will be evaluated recording severe and non-severe adverse events during electrode extraction.
Evaluation of temporality between Invasive cortical depolarization and intracranial hypertension.	during monitoring, maximum 15 days	proportion of patient with Invasive cortical depolarization before, during and after intracranial hypertension.
Evaluation of temporality between Invasive cortical depolarizations and EEG change of rhythm.	during monitoring, maximum 15 days	proportion of patient with Invasive cortical depolarization before, during and after EEG change of rhythm.

Trial Locations

Locations (1)

Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer; 🇫🇷 Bron, France