Personalized Multichannel Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epilepsy: Evaluation of Therapeutic and Neurophysiological Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Seizure frequency
研究概览
简要总结
This project aims to conduct a pilot study based on the targeting of the epileptogenic zone previously localized very precisely by stereoelectroencephalography (SEEG). SEEG is used as part of the pre-surgical assessment. It consists, thanks to the intracerebral implantation of electrodes in the brain of patients, to perform an intracerebral electrophysiological recording and thus to precisely explore the epileptogenic regions.
In order to study the neuromodulatory and therapeutic effects of tDCS on epileptic brains, non-invasive techniques for measuring electrophysiological brain activity such as magnetoencephalography (MEG) and high-resolution electroencephalography (HR EEG) will be used.
Finally, since epilepsy is considered to be a disorder of brain functional networks associated with disturbed brain connectivity, the effects of tDCS on cortical excitability by studying the variations in functional connectivity induced by stimulation will be studied.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Age: Older than 12 years old
- •Patients with drug-resistant focal epilepsy with no surgical indication or with a previous surgical failure or refusing surgery.
- •SEEG previously performed before inclusion with an adequate definition of the epileptogenic zone
- •A clinical or research MRI scan that is suitable for navigated brain stimulation (NBS) and definition of target area.
- •Number of seizures >3/month during the baseline (before the first session of tDCS treatment), for at least 3 months
- •Have stable medications for the whole study duration and few weeks before
- •Total IQ>65
- •Be able to understand, speak and write in French
- •Patient, parents or legally representative who have given written informed consent to allow the study data collection procedures,
- •Be a beneficiary of affiliated to a health insurance plan
排除标准
- •- Generalized epilepsy
- •Presenting contraindication to MRI, a serious intercurrent pathology, a progressive brain tumor
- •Skin conditions (e.g., eczema, lesion)
- •Any cranial metal implants (excluding <1 mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant).
- •Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
- •Metal inside the head (outside the mouth) such as shrapnel, surgical clips
- •Patient currently participating in another clinical trial or having participated in a clinical trial in the month prior to inclusion.
- •Any condition that makes the study subject, in the opinion of the investigator, unsuitable for the study.
- •Person protected by articles L1121-5, L1121-6 and L1121-8 of Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent).
研究组 & 干预措施
tDCS (transcranial direct current stimulation)
Patient will be treated for 3 cycles. A cycle is composed of 5 bi-sessions (one per day) of 20 minutes each.
干预措施: transcranial direct current stimulation (Device)
结局指标
主要结局
Seizure frequency
时间窗: Comparison between baseline and month 8
Percentage of change of seizures frequency
次要结局
- Brain functional connectivity(Comparison between day 1 and day 5 of each session)
- Depression(Comparison between baseline and month 8)
- Anxiety disorders(Comparison between baseline and month 8)
- Seizures evaluation(Comparison between baseline and month 8)