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

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.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage; Brain Lesion; Head Trauma
• Intervention / Treatment: Device: Electrode implantation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Central nervous system monitoring; Each 20 patients will be implanted with subdural or intra cortical electrodes	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): April 7, 2023

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: brain lesions; subdural or intra cortical implanted electrodes; CNS monitor
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Hemorrhage; Trauma, Nervous System; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Subarachnoid Hemorrhage; Craniocerebral Trauma
• Other Study ID Numbers: 69HCL19_0615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No