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Completed

NCT Number: NCT04585503

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

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.

    Time frame: 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 outcomes

  1. Evaluation of electrode implantation safety

    Time frame: during implantation procedure

    Safety will be evaluated recording severe and non-severe adverse events during implantation procedure.

  2. Evaluation of electrode implantation safety

    Time frame: during monitoring, maximum 15 days

    Safety will be evaluated recording severe and non-severe adverse events during monitoring

  3. Evaluation of electrode implantation safety.

    Time frame: during electrode extraction

    Safety will be evaluated recording severe and non-severe adverse events during electrode extraction.

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

    Time frame: during monitoring, maximum 15 days

    proportion of patient with Invasive cortical depolarization before, during and after intracranial hypertension.

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

    Time frame: during monitoring, maximum 15 days

    proportion of patient with Invasive cortical depolarization before during and after oxygen in tissue decreasing.

  6. Evaluation of temporality between Invasive cortical depolarization and detection of a vasospasm

    Time frame: during monitoring, maximum 15 days

    proportion of patient with Invasive cortical depolarization before during and after detection of a vasospasm.

  7. Evaluation of temporality between Invasive cortical depolarizations and EEG change of rhythm.

    Time frame: during monitoring, maximum 15 days

    proportion of patient with Invasive cortical depolarization before, during and after EEG change of rhythm.

  8. Evaluation of temporality between Invasive cortical depolarization and detection of a new cerebral lesion.

    Time frame: during monitoring, maximum 15 days

    proportion of patient with Invasive cortical depolarization before, during and after detection of a new cerebral lesion.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: SD-ICU

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 14, 2020
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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