跳至主要内容
临床试验/NCT07267403
NCT07267403招募中不适用

STIM-PSI: Comparison of Modulations of Motor Brain Activity and SedLine After Median Nerve Stimulation in General Anesthesia

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年10月27日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
48
试验地点
1
主要终点
Motor activity modulations (ERD/ERS) patterns

研究概览

简要总结

To this date, no monitoring device can reliably detect episodes of accidental awakening during general anesthesia. One promising approach is the use of electroencephalography (EEG) to detect movement attempts via a brain-computer interface (BCI). Previous work has shown that combining a BCI with painless median nerve stimulation can detect cerebral motor activity under light propofol sedation. However, clinical data are still lacking regarding the persistence or otherwise of a cerebral motor response (neural synchronization, or ERS) induced by this stimulation during general anesthesia.

In this new study, the aim is to simultaneously record the EEG centered on the motor cortex and the signal from the SedLine Patient State Index (PSI) to better characterize the evolution of cerebral motor activity before, during general anesthesia, and up to awakening. This approach will allow us to explore the complementarity of the two signals for future automated detection of residual states of consciousness during surgery.

Preliminary data from a previous protocol (STIM-MOTANA) allowed to develop an EEG classification algorithm based on Riemannian geometry, capable of inferring a patient's state of consciousness from cortical responses induced by median nerve stimulation.

The objective of this new study is also to compare the sensitivity of this algorithm with that of PSI, in order to assess its potential as a complementary - or even alternative - indicator of the level of consciousness under general anesthesia.

Investigators hypothesize that it is possible to detect, using EEG, specific brain signatures related to median nerve stimulation, including during propofol-induced general anesthesia. Specifically, neuronal desynchronization and resynchronization phases (ERD/ERS), well characterized in wakefulness or light sedation, could partially persist at higher propofol concentrations. Parallel PSI recording will allow analyzing to what extent these EEG modulations are related to classically measured levels of consciousness, and to validate the relevance of the new algorithm based on Riemannian geometry as a tool for detecting intra-operative arousals.

研究设计

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

入排标准

年龄范围
18 Years 至 81 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Right-handed patient
  • Scheduled for surgery using intravenous anesthesia with propofol concentration

排除标准

  • Allergy to propofol, soy, or peanuts.
  • BMI < 20 or > 30
  • Pregnant or breastfeeding women
  • Medical or surgical history that may interfere with median nerve stimulation or EEG signal acquisition (e.g., diabetes, polyneuropathy, central neurodegenerative disease, epilepsy, brain surgery)
  • History of right median nerve injury
  • Right upper limb amputation
  • Upper limb surgery
  • Unable to wear an EEG headset (prone position, head and neck surgery)
  • Drug abuse

结局指标

主要结局

Motor activity modulations (ERD/ERS) patterns

时间窗: During the entire anesthesia

Detection of motor activity modulations (ERD/ERS) induced by median nerve stimulation by means of a EEG algorithm

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tatiana Besse-Hammer

Head of clinical research unit

Brugmann University Hospital

研究点 (1)

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