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临床试验/NCT02574026
NCT02574026已完成1 期

MagnetoEncephaloGraphy Study of Cerebral Activations Induced by Psychomotor Tasks for Target Localisation in View of BCI Clinical Trial

University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2010年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
37
试验地点
2
主要终点
MEG records for functional brain mapping

研究概览

简要总结

The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal volunteers by tapping the finger .

详细描述

Normal healthy (20) volunteers and tetraplegic patients(10) will be submitted to the temporo-spatial mapping of their brain activity, both sensory and motor, induced by a simple behavioral task, consisting on tapping with the finger on a detection pad. This will be done in a light and then dark environment, on a rythm spontaneous and then paced by sound bips. Accelerometric recording will provide the three dimensionnal displacements of the finger as well as the time code.

Brain activity is simultaneously recorded using MEG (306 channels) and EEG (64 channels. Data will be processed by an INPLS algorithm to detect the predictors of activity, their location and time-course.

3D mapping data will be matched with the patient's anatomy provided by 1.5T MRI previously performed.

The aim of the study is to prepare the strategy of implantation of multielectrodes ECoG implants to restore motility in tetraplegic patients in a human BCI protocol currently under development.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female between 18 and 70 years
  • Informed consent
  • Benefiting from Social Security
  • French or english speaking, to understand study procedure
  • Tetraplegic patients : traumatic injury of the cervical spine with retained respiratory autonomy and without associated head injury

排除标准

  • Contra-indication to MRI
  • Claustrophobia
  • Mental disorders
  • All categories of protected persons

结局指标

主要结局

MEG records for functional brain mapping

时间窗: one hour study

This study is not a therapeutic clinical study. No treatment is being delivered.

次要结局

  • MEG measurements during psychomotor tasks(one hour study)
  • EEG measurements during psychomotor tasks(one hour study)

研究者

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

研究点 (2)

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