跳至主要内容
临床试验/NCT04810832
NCT04810832Unknown不适用

EXPRESON-INTRA : Intracerebral Recordings of P3a Responses to Own-names Uttered by Expressive and Neutral Voices in Pharmacoresistant Epilepsy Adult Patients

Centre Hospitalier St Anne1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年9月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Latencies cartography of intracranial responses to own-name uttered by neutral voice

研究概览

简要总结

Neurophysiologic evaluation of disorders of consciousness (DOC) patients in intensive care unit include late auditory evoked potentials. It allows the physicians to record cerebral responses of patients to auditory stimuli and in particularly to their own name (as the P3a response). Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm and notably using more expressive stimuli.

Here the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp with neutral and more expressive stimuli.

详细描述

Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient.

In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices should involves more widespread brain areas than neutral voices processing.

Here the investigators investigate the intracerebral correlates of the P3a responses recorded on the scalp to own-name stimuli uttered by neutral and more expressive voices (positive : smiling voice or negative : rough voice) in adult pharmacoresistant epilepsy patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Basic Science
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

  • •Intractable focal epilepsy with undergoing pre-surgical evaluation
  • •intracerebral electrodes implantation in auditory cortices, temporal lobe, superior temporal gyrus, limbic areas, frontal lobe
  • •Given Consent to inclusion

排除标准

  • •Pregnancy

研究组 & 干预措施

Whole group

Experimental

The whole group undergo the two phases of the study:

  • 1/ They listen successively the 3 oddball paradigms in the department of neurophysiology : P3 own-name recorded by listening to a smiling voice P3 own-name recorded by listening to a neutral voice P3 own-name recorded by listening to a rough voice
  • 2/ They listen successively the same 3 oddball paradigms in the neurosurgical department, during their intractable epilepsy presurgical evaluation : P3 own-name recorded by listening to a smiling voice P3 own-name recorded by listening to a neutral voice P3 own-name recorded by listening to a rough voice

干预措施: Evoked related potentials (Other)

结局指标

主要结局

Latencies cartography of intracranial responses to own-name uttered by neutral voice

时间窗: 1 year

Analyse of latencies of intracranial responses recorded to own-name uttered by neutral voice to build a map of the brain process of this responses

Latencies cartography of intracranial responses to own-name uttered by expressive voices

时间窗: 1 year

Analyse of latencies of intracranial responses recorded to own-name uttered by expressive voices to build a map of the brain process of this responses

次要结局

  • Comparison between brain responses to own-name uttered by expressive voices recorded with intracerebral electrodes versus scalp electrodes(1 year)
  • Comparison between brain responses to own-name uttered by neutral voices recorded with intracerebral electrodes versus scalp electrodes(1 year)

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Sponsor

研究点 (1)

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