Evaluating Modulation Effects of Temporal Interference Using SEEG
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Electrophysiological changes
研究概览
简要总结
This single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy.
详细描述
Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.
Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.
This study aims to investigate the electrophysiological mechanisms of temporal interference (TI) deep brain stimulation by including patients aged 14-60 with implanted intracranial electrodes. During and after TI stimulation, electrophysiological and clinical data will be recorded. Clinical, imaging, and electrophysiological data will be analyzed and processed to advance understanding of TI's effects in deep brain stimulation.
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of drug-resistant epilepsy;
- •No severe systemic diseases;
- •Implantation of stereotactic electrodes;
- •Agreement to participate in this study and signs the informed consent form.
排除标准
- •Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.
研究组 & 干预措施
Temporal Interference
The investigators performed temporal interference (TI) stimulation to patients with drug-resistant epilepsy undergoing SEEG monitoring. They observed electrophysiological activity and clinical manifestations before, during, and after stimulation to investigate the electrophysiological mechanisms of TI.
干预措施: Temporal Interference (Other)
结局指标
主要结局
Electrophysiological changes
时间窗: During the trial(up to 3 hours for each subject)
Electrophysiological waveform changes recorded by stereoelectroencephalography (SEEG) before, during, and after TI stimulation.
次要结局
- Patient's subjective feelings and symptoms(During the trial(up to 3 hours for each subject))
研究者
Liankun_Ren
Professor
Xuanwu Hospital, Beijing