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

NCT ID: NCT04585503

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-04-07

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.

Conditions

Brain Lesion; Head Trauma; Subarachnoid Hemorrhage

Keywords

subdural or intra cortical implanted electrodes; CNS monitor; brain lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Central nervous system monitoring

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

Group Type: EXPERIMENTAL

Electrode implantation

Intervention Type: DEVICE

The intervention consist in implanting 6 electrodes in subdural or intra cortical position and monitor the central nervous system activity. This monitoring will be additional to the usual monitoring.

Interventions

Electrode implantation

The intervention consist in implanting 6 electrodes in subdural or intra cortical position and monitor the central nervous system activity. This monitoring will be additional to the usual monitoring.

Intervention Type: DEVICE

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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer

Bron, , France

Countries

France

References

Ghibaudo V, Bado J, Garcia S, Berthiller J, Rithzenthaler T, Gobert F, Bapteste L, Carrillon R, Bodonian C, Dailler F, Haegelen C, Dumot C, Rheims S, Berhouma M, Balanca B. Lessons to Learn from Multimodal Neuromonitoring of Brain Death with Electrophysiological Markers of Cortical and Subcortical Loss of Functions. Neurocrit Care. 2024 Dec;41(3):1110-1114. doi: 10.1007/s12028-024-02049-4. Epub 2024 Jul 9. No abstract available.

Reference Type: RESULT

PMID: 38982002 (View on PubMed)

Balanca B, Ghibaudo V, Bado J, Berthiller J, Ritzenthaler T, Gobert F, Bapteste L, Carrillon R, Bodonian C, Contard F, Percevault G, Marinesco S, Dreier JP, Woitzik J, Haegelen C, Rheims S, Dumot C, Dailler F, Berhouma M. Feasibility and safety of electrocorticography monitoring after acute brain injury to detect cortical spreading depolarisation, a prospective observational study in a neurological intensive care unit. Anaesth Crit Care Pain Med. 2025 Nov 13:101669. doi: 10.1016/j.accpm.2025.101669. Online ahead of print.

Reference Type: DERIVED

PMID: 41241268 (View on PubMed)

Other Identifiers

69HCL19_0615

Identifier Type: -

Identifier Source: org_study_id