NCT04560959Unknown1 期
An Atlas of Cerebral Responses to the Stimuli of the tACS Recorded by SEEG
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 主要终点
- Changes of intracranial activities
研究概览
简要总结
By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS,
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
- 14 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All epileptic patients that would receive the implantation of SEEG electrodes, regardless of the seizure locations;
- •There was no metal implantation before;
- •Eligible for MRI examination;
- •No other lesional neurological disorders;
- •Could be well informed by the study protocols.
排除标准
- •Suffered from any other mental illnesses prior to the enrollment;
- •Those suffering from the serious or unstable organic diseases;
- •Pregnant or lactation women, and those who have a plan of pregnant;
- •Patients with central nervous system tumors, acute brain injury or infection;
- •Skin injured, or allergic to the exposure of the conductive gel;
- •Those with implanted devices;
- •Those who received modified electrical convulsive therapy, or TMS within the recent one month;
- •The score of item 3 (suicidal item) in HAMD-17 equal or greater than 3;
- •Enrolled in any other on going trials;
- •Other situations evaluated by the researchers as inappropriate to the enrollment
结局指标
主要结局
Changes of intracranial activities
时间窗: Within 250 ms immediately after the stimulation.
The change of the power in a band of 0-200 HZ according to the intracranial EEG recording.
次要结局
- Frequency of the epileptic discharges(50 minutes during the stimulation and 50 minutes of the interictal baseline before the intervention during the same hour of the day)
- Event related potential (ERP)(Baseline: 24 hours before the tACS intervention; Observation: Immediately after the end of the tACS intervention.)
研究者
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