跳至主要内容
临床试验/NCT06438419
NCT06438419招募中不适用

Parkinsonism-Related Oscillations in the Cortico-Basal Ganglia-Thalamic Network During Movement: Beyond the Frequency Range

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年4月16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
20
试验地点
1
主要终点
Cortico-subcortical electrophysiological coherence

研究概览

简要总结

Expression of hypokinetic and hyperkinetic motor symptoms in Parkinson's disease (PD) is associated with pathological synchronous oscillations of neuronal activity (local field potential/LFP) in the cortico-subcortical network with a wide frequency range. In the present project, we propose to study cortico-subcortical oscillations and their synchronization in patients operated for PD (subthalamic deep brain stimulation (STN-DBS)) during distinct pharmacological and stimulation conditions (hypokinetic and hyperkinetic), using a simple motor task.

详细描述

To define the link between the characteristics of neuronal oscillations (frequency, amplitude, phase relationship) within the cortico-subcortical network and the movement, we designed a simple motor task of gripping/pulling a lever. The LFPs will be collected at the cortical and subcortical levels (STN) during the motor task using a high-resolution EEG (HR-EEG) and the Percept™ system (Medtronic). Recordings will be realized in four conditions: without pharmacological treatment and without stimulation (Off condition), without pharmacological treatment and during stimulation (DBS condition), during pharmacological treatment and without stimulation (DOPA condition) and during pharmacological treatment and stimulation (DOPA+DBS condition).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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
  • 18 to 75 years-old
  • With idiopathic Parkinson's disease
  • Having a STN-DBS with a PERCEPT™ for less than a year or being candidate for STN-DBS with the PERCEPT™ device (first-implantation)
  • Able to perform the simple motor task
  • Patients covered by a health insurance 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 (curatorship, guardianship) 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

Cortico-subcortical electrophysiological coherence

时间窗: At inclusion (Day 0)

Statistically significant difference in the cortico-subcortical electrophysiological coherence value between a movement performed in hypokinetic condition and a movement performed in hyperkinetic condition

次要结局

  • Spectral signal power(At inclusion (Day 0))
  • Effect of STN-DBS on spectral signal power(At inclusion (Day 0))
  • Correlation between semiological characteristics(At inclusion (Day 0))

研究者

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

研究点 (1)

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