NCT02960347已完成不适用
Examining the Efficacy of tDCS in the Attenuation of Epileptic Paroxysmal Discharges and Clinical Seizures
Herzog Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- change in seizure frequency from baseline
研究概览
简要总结
The current study examined the feasibility of High-Definition tDCS (HD-tDCS) in reducing epileptiform activity in a 30-month-old child suffering from early onset epileptic encephalopathy. HD-tDCS was administered over 10 intervention days spanning two weeks including pre- and post-intervention video-electroencephalography (EEG) monitoring.
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
- 10 Months 至 36 Months（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Initial diagnosis of Ohtahara syndrome/West syndrome/ Lennox-Gastaut syndrome by a pediatric neurologist using video-EEG
- •Ongoing synchronous Hypsarrhythmia
- •Modified Hypsarrhythmia with a consistent focus of paroxysmal discharges
- •Signed informed consent of parents/immediate legal guardian
- •Age 10 to 36 months
- •Infant should be in a steady state indicated by a baseline test of electrolytes and biochemistry blood test, heart rate, temperature, respiratory rate, and saturation.
排除标准
- •Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- •History of adverse reaction to neurostimulation
- •Significant ECG abnormality
研究组 & 干预措施
Active tDCS
Experimental
open label active tDCS treatment
干预措施: High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor (Device)
结局指标
主要结局
change in seizure frequency from baseline
时间窗: day 1, day 3, day 5, day 6, day 8, day 10, day 13, day 20, day 27, day 33, day 40, day 50
次要结局
未报告次要终点
研究者
研究点 (1)
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