跳至主要内容
临床试验/NCT04560959
NCT04560959Unknown1 期

An Atlas of Cerebral Responses to the Stimuli of the tACS Recorded by SEEG

Xuanwu Hospital, Beijing0 个研究点目标入组 30 人开始时间: 2020年9月20日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

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