Transcranial Direct Current Stimulation for Treatment of Childhood Pharmacoresistant Lennox-Gastaut Syndrome, A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Number of Seizure After Treatment by tDCS
研究概览
简要总结
Background: Lennox-Gastaut syndrome (LGS) is a severe childhood epileptic syndrome with high pharmacoresistance. The treatment outcomes are still unsatisfied. The investigator previous study of cathodal transcranial direct current stimulation (tDCS) in children with focal epilepsy showed significant reduction in epileptiform discharges. The investigator hypothesized that cathodal tDCS when applied over the primary motor cortex (M1) combined with pharmacologic treatment will be more effective for reducing seizure frequency in participants with LGS than pharmacologic treatment alone.
Material and Method:
Study participants were randomized to receive either:
- pharmacologic treatment with 5-consecutive days of 2 milliampere (mA) cathodal tDCS over M1 for 20 min or
- pharmacologic treatment plus sham tDCS. Measures of seizure frequency and epileptic discharges were performed before treatment and again immediately post-treatment and 1-, 2-, 3-, and 4-week follow-up.
详细描述
Participant recruitment and informed consent Study participants were recruited via advertisement at the pediatric outpatient department, Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Thailand. The study procedures were described to any eligible participants who expressed an interest in participating in the study by a pediatric neurologist.
Criteria for LGS were defined according to the triad of:
- polymorphic intractable seizures that are mainly tonic, atonic, and atypical absence seizures,
- cognitive and behavioral abnormalities,
- EEG with paroxysms of fast activity and slow (less than 2.5 Hz) generalized spike-wave discharges (GSWD).
The diagnosis was confirmed by a pediatric neurologist using the thoroughly history taking, physical examination, EEG, and brain MRI.
Study inclusion criteria included:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of LGS
- •Failure of more than two first-line AEDs to control seizures
- •Average seizure frequency of more than one per month for 18 months and no more than three consecutive seizure-free months during that interval
- •Age between 6 and 15 years
排除标准
- •Drug addiction
- •Pregnancy
- •Skull defect
- •Other serious neurological diseases and change in dosage of antiepileptic drugs or use of herbal remedies and other alternative therapies.
结局指标
主要结局
Number of Seizure After Treatment by tDCS
时间窗: Baseline, 4 Weeks
次要结局
- Number of Epileptic Discharge After Treatment by tDCS(Baseline, 4 Weeks)
研究者
Paradee Auvichayapat
Head of Noninvasive Brain Stimulation Research Group of Thailand, Department of Physiology; Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.
Khon Kaen University