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临床试验/NCT07842458
NCT07842458招募中不适用

Depth Electrode Cortical Reverberation Monitoring After Traumatic Brain Injury

Samuel Cramer1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Number of Participants With ≥24 Hours of Artifact-Controlled Cortical Reverberation Recordings Suitable for Analysis

研究概览

简要总结

This is a preliminary, prospective interventional feasibility study to investigate the use of cortical reverberation (CR) monitoring in patients with traumatic brain injury (TBI) requiring a clinically indicated external ventricular drain (EVD) placement.

详细描述

Traumatic brain injury (TBI) is a major cause of death and disability and imposes burden on the health-system and society. Beyond the first impact of the injury, secondary brain injury processes, include elevated intracranial pressure (ICP), impaired autoregulation, seizures, and cortical spreading depolarizations (CSDs). These effects drive lesion expansion and worsen outcomes. Observational cohorts show that CSDs are common after severe TBI and that higher CSD burden results in worse recovery.

This is a preliminary, prospective interventional feasibility study to investigate the use of cortical reverberation (CR) monitoring in patients with traumatic brain injury (TBI) requiring a clinically indicated external ventricular drain (EVD) placement. EVDs are required to monitor and manage significant intracranial pressure. During standard-of-care EVD placement at the bedside in the intensive care unit (ICU), a single multi-contact depth electrode will be placed adjacent to the EVD catheter through the same burr hole. The electrode will be connected to a stimulator and recording system. Biphasic, charge-balanced intracortical pulses (1-6 mA, 60-1000 µs) will be delivered between adjacent contacts once every 3 seconds (0.33 Hz) for the duration of monitoring. Continuous electrocorticography (ECoG) will be recorded from the same electrode contacts. Recordings will be reviewed daily by a study neurosurgeon or an epileptologist for evidence of electrographic seizure activity. CR responses will be analyzed offline to assess feasibility, signal quality, and correlation with concurrent physiologic measures obtained from multimodal monitoring. The duration of study monitoring will be determined by the length of time that invasive neuromonitoring is clinically indicated. The depth electrode will be removed at the bedside once EVD monitoring is discontinued or the patient is discharged from the ICU.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
否

入选标准

  • •18 years or older
  • •Consenting party must be able to provide written consent in English
  • •Patient recommended to undergo EVD placement for the monitoring and possible treatment of ICP after TBI

排除标准

  • •Contaminated scalp lacerations
  • •Known systemic infection
  • •Non-English speaking
  • •Fixed, uncorrectable coagulopathy
  • •Pregnant, minors, or wards of the state

研究组 & 干预措施

TBI Patients

Other

This is a single-arm study.

干预措施: A multi-contact depth electrode (Device)

结局指标

主要结局

Number of Participants With ≥24 Hours of Artifact-Controlled Cortical Reverberation Recordings Suitable for Analysis

时间窗: through study completion, up to two years

A depth electrode is placed through the existing external ventricular drain (EVD) burr hole and used to deliver intracortical stimulation and record cortical reverberation (CR) responses. A participant is counted as meeting the endpoint if ≥24 cumulative hours of CR recording are obtained that pass predefined criteria and are judged suitable for feature extraction.

次要结局

  • Amplitude of Cortical Reverberation Response(through study completion, up to two years)
  • Duration of Cortical Reverberation Response(through study completion, up to two years)
  • Decay Slope of Cortical Reverberation Response(through study completion, up to two years)
  • Latency of Cortical Reverberation Response(through study completion, up to two years)

研究者

发起方
Samuel Cramer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Samuel Cramer

Principal Investigator

Hennepin Healthcare Research Institute

研究点 (1)

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