跳至主要内容
临床试验/NCT06432907
NCT06432907招募中不适用

Decoding of Neuronal Potentials Associated With Motor Performance and Motor Imagery Obtained Using Intracranial stereoEEG Electrodes

Research Center of Neurology, Russia2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2024年6月6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
Rate of BCI classification recall

研究概览

简要总结

The goals of this study are (1) to evaluate the rate of stereoEEG brain-computer interface (BCI) classification accuracy and (2) to collect the dataset of neuronal signals recorded from stereoEEG electrodes during motor performance, motor imagery or brain-computer interface control. The study enrolls hospitalised patients suffering from resistant epilepsy with already implanted intracranial stereoEEG electrodes for medical reasons (i.e. for preoperative localization of the epileptogenic foci). The number and location of electrodes are determined solely for the clinical purposes of stereoEEG monitoring and are not related to the protocol of the current study.

After obtaining informed consent to participate in the study, each patient will participate in one experimental session lasting no more than 60 minutes, recording brain signals associated with hand movement, motor imagery, and BCI control. All tasks and instructions presented during the study session are not pro-epileptogenic and cannot provoke an epileptic attack. The experiments will take place in the patient's room, without interruption of observation by the department's medical staff.

The data recorded in this study will be used to improve or develop new algorithms for decoding motor signals from deep brain structures for their potential use in invasive BCIs.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male and female patients who have had stereoEEG electrodes implanted for medical reasons;
  • voluntary informed consent to participate in the study;
  • age from 18 to 70 years.

排除标准

  • patient refusal to participate in the study;
  • cognitive impairment that prevents following the study instructions;
  • severe visual impairment that does not allow viewing visual instructions on a computer screen;
  • upper limb paresis or other motor disorders;
  • pain in the hand of any etiology;
  • any acute diseases, exacerbation of chronic diseases, acute life-threatening conditions;
  • occurrence of an epileptic attack during the experiment.

结局指标

主要结局

Rate of BCI classification recall

时间窗: During the procedure

The proportion (%) of cases with correct identification of the task among all presentations of the corresponding command.

次要结局

未报告次要终点

研究者

发起方
Research Center of Neurology, Russia
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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