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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Central nervous system monitoring | Experimental | Each 20 patients will be implanted with subdural or intra cortical electrodes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Anesthésie réanimation Groupement hospitalier Est, hôpital Pierre Wertheimer | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38982002 | Result | 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. | |
| 41241268 |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D020300 | Intracranial Hemorrhages |
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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 |
| Derived |
| 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. 2026 Jul;45(4):101669. doi: 10.1016/j.accpm.2025.101669. Epub 2025 Nov 13. |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |