Optimized and Personalized Trans-cranial Brain Stimulation in Partial Refractory Epilepsies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline of remaining seizure number
研究概览
简要总结
Epilepsy is one of the most common neurological diseases, affecting between 0.5% and 1% of the general population. Therefore, new diagnostic and treatment methods are having a big impact on society. Epilepsy is also one of the most commonly diagnosed pediatric neurological disorders, with long-term implications for the quality of life of those affected and their relatives. In only two-thirds of cases, seizures can be adequately controlled with anticonvulsant drug therapy. For other patients with a drug-resistant focal epilepsy (up to around 2 million in Europe) epilepsy surgery is currently the most effective treatment. However, only 15-20% of these drug-resistant patients are eligible for epilepsy surgery. This is either because the cortical epileptogenic zone cannot be localized with sufficient precision with standard diagnostic means, or because the epileptogenic zone overlaps meaningful cortical areas, so that it cannot be surgically removed without considerable neurological deficit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient, male or female aged 1 to 18, with refractory partial epilepsy considered potentially surgical according to the definition of ILAE. Drug-resistant epilepsy can be defined as the failure of adequate therapeutic trials of two antiepileptics (either monotherapy or in combination) so that the patient is free from seizures on a lasting basis.
- •Any epileptic patient with interictal epileptic spikes on his standard or High Resolution EEG and or on the Magnetoencephalography examination
- •Any epileptic patient undergoing a structural MRI
- •Any patient who has agreed to participate in the PerEpi 1 study allowing the optimization of the location of epileptic sources and the modelling of the optimization of the parameters of transcranial electrical stimulation
- •Patients who have at least 4 seizures per month
排除标准
- •Patient not meeting the age criteria
- •And/or presenting generalized epilepsy
- •And/or presenting diffuse interictal peaks and/or presenting a serious alteration of the general condition and vital functions
- •And/or in the event of refusal by one of the parents or the child
- •Pregnant, parturient or breastfeeding woman.
- •Contraindication to the use of mc-tDCS stimulation without seizure
结局指标
主要结局
Change from baseline of remaining seizure number
时间窗: 10 weeks
evaluation a new procedure of non-invasive, individualized and optimized transcranial electrical stimulation therapy in the management of pharmaco-resistant focal epilepsies during a study allowing to identify a "proof of concept", in particular for patients who are not eligible for epilepsy surgery
次要结局
未报告次要终点