BRAINSTIM : Effects of Transcranial Direct Current Stimulation (TDCS) in Drug-resistant Partial Epilepsy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.
研究概览
简要总结
Drug-resistant partial epilepsy has a heavy impact on quality of life and sometimes on life expectancy itself. Only a minority of patients may benefit from a curative epilepsy surgery. Neurostimulation, which can be an effective add-on treatment, is currently mainly represented by vagus nervus stimulation. Transcranial direct current stimulation, a non -invasive technique already used in other areas of neurology, may be efficient on some partial epilepsies, in particular through the individual configuration of stimulation, made possible by recent technological advances.
Main goal : To study the effect of transcranial electrical stimulation on the frequency of seizures in patients with drug-resistant partial epilepsy.
Hypothesis : Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 15 years;
- •Patients with drug-partial resistant epilepsy with the following characteristics:
- •Disabling epilepsy despite an optimized pharmacological treatment.
- •An average of one seizure a day or more during the week preceding the inclusion
- •Focal epilepsy in which epileptogenic zone is documented by paraclinical examinations consistent with clinical data
- •Existence of measurable EEG markers of epilepsy
- •Anti-epileptic drug treatment unmodified during the 2 weeks preceding the inclusion no change to treatment planned during the study.
- •Signed informed consent.
排除标准
- •Patients under 15 years;
- •Patients in which a standard quality EEG recording is not possible
- •Patients with ictal bradycardia or ictal syncope ;
- •Patients with heart disease which may result in heart arrhythmia ;
- •Incapacitated patients (curatorship, guardianship), patients deprived of liberty.
- •Pregnant or lactating women
- •Vagus nervus stimulation is not an exclusion criteria
研究组 & 干预措施
TDCS session
Intervention : Stimulation is applied during a 60 min session with STARSTIM
干预措施: STARSTIM (Device)
TDCS Placebo
Intervention : Stimulation is not applied during a 60 min session with STARSTIM
干预措施: sham TDCS (Device)
结局指标
主要结局
Reduction of 50% or more in the frequency of occurrence of seizures within 24 hours following an individually configured TDCS session: responders in real TDCS vs placebo stimulation.
时间窗: 24 hours
次要结局
- Electrophysiological : Decrease of epileptic EEG paroxysms at 8 and 24 hours after a TDCS session(8-24 hours)
- Clinical : - Reduction in the duration of seizures(6 months)
- Clinical : - Significant reduction of the frequency of occurrence of seizures within 24 hours, 48 hours, and 7 days following a session of TDCS.(24 hours until 7 days)
- Electrophysiological : - Decrease of epileptic EEG paroxysms immediately following a TDCS session.(up to 1 min)
- - Clinical : If appropriate, reduction of the frequency of occurrence of secondary generalized seizures.(6 months)
- -Clinical : Improvement in the quality of life within 7 days following a TDCS session(7 days)