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

Subarachnoid Hemorrhage Clinical Trial

— SD-ICU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04585503
• Other study ID #: 69HCL19_0615
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: April 7, 2023

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 7, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Brain Lesion
• Craniocerebral Trauma
• Head Trauma
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
France	Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of electrode implantation safety	Safety will be evaluated recording severe and non-severe adverse events during implantation procedure.	during implantation procedure
Secondary	Evaluation of electrode implantation safety	Safety will be evaluated recording severe and non-severe adverse events during monitoring	during monitoring, maximum 15 days
Secondary	Evaluation of electrode implantation safety.	Safety will be evaluated recording severe and non-severe adverse events during electrode extraction.	during electrode extraction
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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