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临床试验/NCT06241924
NCT06241924招募中不适用

Oscillatory Activity in Basal Ganglia Circuits During Normal and Pathological Movement

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
difference in the cortico-subcortical electrophysiological coherence value

研究概览

简要总结

The expression of hypokinetic and hyperkinetic motor symptoms is accompanied by pathological synchronous oscillations of neuronal activity in this cortico-subcortical network with a wide frequency range.

The purpose of this research is to study cortico-subcortical oscillations and their synchronization in two pathologies emblematic of hypokinetic (Parkinson's disease) and hyperkinetic (epilepsies) phenomena using a simple motor task and comparing different situations.

详细描述

In order to define the link between the characteristics of the oscillations (frequency, amplitude, phase relation) within this cortico-subcortical network and movement (normal or pathological) in humans, a simple motor task of gripping/pulling a lever has been designed.

The local field potentials (LFPs) will be collected during the same motor task in :

i) patients with Parkinson's disease, using a high-resolution electroencephalogram (EEG) and the PERCEPT(TM) system (Medtronic) equipped with a "sensing" function for deep LFP recordings and in EEG-HR (for high resolution) for cortical recordings

ii) patients with focal drug-resistant epilepsy, during a pre-surgical assessment by stereo-electro-encephalography (SEEG). The SEEG allows the recording of both the cortex and the subcortical regions in a concomitant manner, and a direct correlation can be studied.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female
  • Between 18 and 75 years of age
  • With Parkinson's disease and already operated with implantation of electrodes in the Subthalamic nucleus connected to a PERCEPT (TM) device.
  • Giving free, informed, written consent signed by the participant and the investigator Or
  • With drug-resistant epilepsy and benefiting from a phase II pre-surgical assessment with intracerebral electrophysiological exploration by stereo-EEG
  • With at least one electrode exploring the basal ganglia or the thalamus.
  • Able to perform the simple motor task
  • Affiliated or beneficiary of a social security scheme;
  • Giving free, informed, written consent signed by the participant and the investigator

排除标准

  • Be incapable of giving consent personally
  • Be subject to a legal protection measure or be placed under judicial protection;
  • Being pregnant or breastfeeding
  • Present a serious and/or decompensated somatic or psychiatric illness

结局指标

主要结局

difference in the cortico-subcortical electrophysiological coherence value

时间窗: Day 1

difference in the cortico-subcortical electrophysiological coherence value between normal movement (control condition) and hypo- or hyperkinetic pathological movement

次要结局

未报告次要终点

研究者

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

研究点 (2)

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