Evaluating Biomarkers of Temporal Interference for Temporal Lobe Epilepsy Under SEEG
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of interictal electrophysiological biomaker changes in epilepsy
研究概览
简要总结
This study evaluates the effect of temporal interference (TI) stimulation on biomarkers in patients with temporal lobe epilepsy (TLE) under stereo-electroencephalography (SEEG), and provides theoretical basis for non-invasive TI treatment of temporal lobe epilepsy.
详细描述
10 patients aged 18-65 years with TLE assessed by semiology, video electroencephalogram and imaging in Epilepsy Center of Xijing Hospital (Xi'an, China) will be recruited. Clinical baseline data such as general information and history of seizures will be collected. The SEEG electrodes were implanted in the Department of neurosurgery of Xijing Hospital and after 24 hours TI will be performed with continuous SEEG monitoring. Finally, the biomarker changes of EEG signals before and after TI treatment were statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of drug refractory epilepsy and temporal lobe epilepsy;
- •Patients undergoing SEEG;
- •Able to cooperate the treatment and related inspection;
- •Fully understands and signs informed consent.
排除标准
- •Patients with temporal plus epilepsy;
- •In status epilepticus;
- •With other severe disease;
- •Pregnancy or lactation women;
- •Unable to tolerate SEEG or TI;
- •At the same time to participate in other clinical trials;
- •Withdraw consent procedure.
结局指标
主要结局
Number of interictal electrophysiological biomaker changes in epilepsy
时间窗: 24 hours after TI stimulation
Electrophysiological biomarkers changes recorded by SEEG through the experiment.
次要结局
未报告次要终点