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临床试验/NCT04585503
NCT04585503已完成不适用

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

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Evaluation of Invasive cortical depolarization (SD) recorded in a non-expert center with subdural or intra cortical implanted electrode and central nervous system monitoring.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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,

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Evaluation of temporality between Invasive cortical depolarization and detection of a vasospasm(during monitoring, maximum 15 days)
  • Evaluation of temporality between Invasive cortical depolarization and detection of a new cerebral lesion.(during monitoring, maximum 15 days)
  • Evaluation of temporality between Invasive cortical depolarization and oxygen in tissue decreasing pressure(during monitoring, maximum 15 days)
  • 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 depolarizations and EEG change of rhythm.(during monitoring, maximum 15 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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