Cathodal Transcranial Direct Current Stimulation in Patients With Drug-resistant Focal Epilepsy: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in epileptic discharge frequency at 12th week after tDCS compared to baseline epileptic discharge frequency
研究概览
简要总结
The basis of this project is the application of cathodal tDCS in patients with drug-resistant focal epilepsy including patients whose seizures persist after epilepsy surgery, who rejected epilepsy surgery, and/or who are not suitable for surgery. For this purpose, 5-day consecutive cathodal electrical stimulation sessions will be used with personalized electrode montage according to the patient's seizure focus. In this context, the changes in seizures frequency and epileptic discharges will be examined for the first week and 12th week after the tDCS sessions through the seizure diary of the patients and the electroencephalogram (EEG) recordings to be taken. In addition, changes in cognitive functions, mood, and quality of life will be examined in patients after the intervention.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older,
- •Diagnosed with focal epilepsy with epileptic focus determined according to clinical and electroencephalogram recordings, who have undergone epilepsy surgery but seizures persist, who refuse epilepsy surgery or who are considered unsuitable for surgery,
- •Patients who comply with the definition of drug-resistant epilepsy according to ILAE (International League Against Epilepsy Classification) criteria (Patients who have failed to achieve long-term seizure-free status despite at least two appropriate antiepileptic drugs given alone or in combination),
- •Minimum 1 or more seizures per month (minimum 3 months),
- •No antiepileptic dose change until 3 weeks before the study, stable treatment, and no dose change planned during the study,
- •At least 1.5 Tesla MR imaging was performed before the study,
- •Signed the informed consent form or the consent form signed by the legal representative,
- •EEG was present before the study and all EEG data was accessible,
- •Cooperative patients who can speak, understand and communicate in Turkish will be recruited.
排除标准
- •The presence of any disease/deformity in the patient that the researchers believe will affect the patient's safety or the reliability of the data to be collected,
- •Detection of more than one seizure focus in the patient,
- •The patient had a psychogenic non-epileptic seizure attack (Psychogenic Non-epileptic Seizures -PNES) within 2 years prior to the study,
- •Having a generalized onset seizure,
- •Having had status epilepticus in the last 1 year,
- •Presence of any disease, medical condition, or physical condition that, according to the researchers, could prevent, limit, affect or reduce the subject's completion of a minimum period of 1 + 12 weeks,
- •Tissue damage (eczema, etc.) in the area where tDCS will be applied on the skin,
- •Patients who are pregnant and do not use/do not want to use contraception during the study period,
- •Lactating women,
- •Metal implants, fillings in the head or teeth, presence of a medical device in the body (pacemaker, deep brain stimulator, cochlear implant, nerve stimulator, etc.)
- •Presence of a skull defect with a radius of 5 mm and/or larger remaining from previous surgeries,
- •The patient is participating in another clinical trial.
结局指标
主要结局
Changes in epileptic discharge frequency at 12th week after tDCS compared to baseline epileptic discharge frequency
时间窗: At the 12th week of follow-up after tDCS
EEG recordings will be obtained after tDCS sessions. Epileptic discharges will be calculated from 30 minutes recordings. EEG will be recorded with scalp electrodes using a 128-channel Natus Quantum (Natus Medical) with a sampling rate 2048 Hz and 21 channels.
Changes in epileptic seizure frequency at 12th week after tDCS compared to baseline (before the tDCS)
时间窗: 3 months follow-up after tDCS
The seizure diary of the patients will be recorded for 3 months follow-up after tDCS sessions. The seizure frequency will be evaluated in comparison to pre-tDCS seizure frequency.
Changes in epileptic discharge frequency at 1st week after tDCS compared to baseline epileptic discharge frequency
时间窗: At the 1st week of follow-up after tDCS
EEG recordings will be obtained after tDCS sessions. Epileptic discharges will be calculated from 30 minutes recordings. EEG will be recorded with scalp electrodes using a 128-channel Natus Quantum (Natus Medical) with a sampling rate 2048 Hz and 21 channels.
次要结局
- Quality of Life in Epilepsy Inventory (QOLIE-31)(At the 1st week and 12th week of follow-up after tDCS)
- Epworth Sleepiness Scale(At the 1st week and 12th week of follow-up after tDCS)
- Depression Anxiety and Stress Scale 21 (DASS-21)(At the 1st week and 12th week of follow-up after tDCS)
- Pittsburgh Sleep Quality Index (PSQI)(At the 1st week and 12th week of follow-up after tDCS)