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临床试验/NCT03114748
NCT03114748Unknown不适用

Monitoring électroencéphalographique Chez Les Patients traités Par Stimulation cérébrale Profonde

University Hospital, Grenoble0 个研究点目标入组 60 人开始时间: 2012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
发起方
入组人数
60
主要终点
EEG recordings from 96 scalp electrodes

研究概览

简要总结

This protocol aims to develop the use of behavioral and electroencephalographic measures during cognitive tasks in patients treated with deep brain stimulation during the stimulation parameters adjustments. The main clinical goal of this protocol is to find behavioral and or electroencephalographic markers to evaluates the right targeting of stimulation electrodes. On the more fundamental point of view, the study of those data can be used to understand better the action mechanisms of deep brain stimulation.

详细描述

This protocol aims to understand how brain regions are modulated by deep brain stimulation using scalp electroencephalographic recordings. This protocol covers many pathologies which are thought to relate to different brain networks impairements and are therefore complementary in the understanding of cortical activation and modulation of this activation by deep brain stimulation. These diseases are motor (parkinson..) and psychiatric (obsessive compulsive disorders, treatment resistant depression..). To activate brain networks of interest, either implicating brain regions dysfunctional in the diseases or brain regions stimulated by the electrode, the investigators can use cognitive task which are know to involve those networks, for instance motor task for motor diseases as clicking with a computer mouse when presented with a specific type of stimulus on the screen. EEG recordings can then be processed to retrieve cortical activation and modulation of this activation with stimulation (using an ON DBS OFF DBS procedure) during task processing. These data are also very precious to study brain dynamic networks and their modulation by DBS. After analysis of these results, this protocol aims to be used in order to refine targeting, for instance when correlating cortical modulation with DBS and clinical improvement with electrode positions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • patient treated with DBS
  • study inclusion written agreement by the patient or his legal representant
  • intellectual capacities compatible with cognitive task and EEG recordings
  • French native speaker and capacity to understand the study processes and particularly to fill in the auto questionaires
  • patients abled to give an enlighted agreement
  • patients who have an health insurance coverage

排除标准

  • people who fill in the articles L1121-5 to L1121-8 or the Public Health Code
  • patients who don't stand the transient interruption of stimulation
  • severe concomitant disease
  • disease which impose a treatment which modulates vigilance
  • cognitive alteration (Mattis<130)

研究组 & 干预措施

EEG

Experimental

2 scalp electroencephalographic (EEG) recording will be acquired in ON and OFF DBS conditions

干预措施: EEG (Other)

DBS ON and OFF

Experimental

DBS is turned ON and OFF in the 2 EEG sections

干预措施: DBS switched OFF and ON (Other)

结局指标

主要结局

EEG recordings from 96 scalp electrodes

时间窗: around 15 minutes for each condition

high resolution voltage signal from the patients scalp

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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