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

NCT04585503 | Completed DMC

• 1 other identifier: 69HCL19_0615
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  18 months

Secondary Outcomes (8)

• Evaluation of electrode implantation safety

  during implantation procedure

• Evaluation of electrode implantation safety

  during monitoring, maximum 15 days

• Evaluation of electrode implantation safety.

  during electrode extraction

• Evaluation of temporality between Invasive cortical depolarization and intracranial hypertension.

  during monitoring, maximum 15 days

• Evaluation of temporality between Invasive cortical depolarization and oxygen in tissue decreasing pressure

  during monitoring, maximum 15 days

Study Arms (1)

Central nervous system monitoring

EXPERIMENTAL

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

Device: Electrode implantation

Interventions

Electrode implantation 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.

Central nervous system monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

Related Publications (2)

• 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.

  PMID: 38982002 RESULT

• 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.

  PMID: 41241268 DERIVED

MeSH Terms

Conditions

Craniocerebral Trauma; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: January 1, 2021
• Primary Completion: April 7, 2023
• Study Completion: April 7, 2023
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)