Application of Targeting Transcranial Direct Current Stimulation (tDCS) Stimulation in the Treatment of Refractory Status Epilepticus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus
研究概览
简要总结
The purpose of the study is to assess the efficacy and safety of targeting tDCS stimulation for treatment of Refractory status epilepticus
详细描述
After being informed about the study and potential risks, the recruited patients, giving written informed consent, will be determined of the eligibility for study entry. The patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tDCS stimulation (up to 10 times) or sham stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 14 and 80 year-old with Gender unlimited,
- •Suitable for EEG monitoring;
- •Clinical diagnosis of Refractory status epilepticus (status epilepticus that cannot be controlled by two types of antiepileptic drugs and at least one anesthetic);
- •Informed consent to participate in this study was obtained from the participants or their surrogates
排除标准
- •Unstable vital signs (systolic blood pressure<90mmHg, heart rate<60 beats/min, pulse oxygen saturation<90%);
- •Having severe skull injury/defect or medical equipment implanted in the head;
- •Pregnancy;
- •With any implantable electronic instrument (including pacemakers, vagus nerve stimulators) or metal implanted devices.
研究组 & 干预措施
TDCS sham-stimulation group
The duration and frequency of tDCS treatments in the sham-stimulation group are the same as those in the treatment group, but the tDCS device is not active during the 20 minutes of sham-stimulation.
干预措施: TDCS sham-stimulation (Device)
tDCS treatment group
In the real tDCS stimulation group, direct cathodal current at 2 mA was delivered by a tDCS device over the seizure onset zone. Anode was on the contralateral forehead. Treatment was for 20 min, repeated twice in a day, then again over the next few days. The maximum number of stimuli required to terminate the status epilepticus should not exceed 10.
干预措施: tDCS stimulation (Device)
结局指标
主要结局
Number of participants with status epilepticus termination between tDCS treatment group and tDCS sham--stimulation group as assessed by Salzburg Consensus Criteria for Non-Convulsive Status Epilepticus
时间窗: through study completion, an average of 1 year
Outcomes will be assessed by clinical observation and EEG evaluation before 10 times of tDCS stimulation between both groups
次要结局
- Number of participants with treatment-related adverse events between tDCS treatment group and tDCS sham--stimulation group(through study completion, an average of 1 year)
研究者
Weibi Chen
associate professor
Xuanwu Hospital, Beijing