A Study on the Efficacy and Mechanism of Targeted Cerebellar Transcranial Electrical Stimulation for the Treatment of Refractory Temporal Lobe Epilepsy: A Single-center, Observational Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Compared to baseline, the reduction rate of epileptic seizure frequency
研究概览
简要总结
Study the therapeutic effect and potential neural mechanisms of transcranial electrical stimulation targeting the cerebellum for the treatment of refractory temporal lobe epilepsy through MRI and EEG.
详细描述
This study is a single-center, observational study.This study applies transcranial alternating current stimulation to the cerebellum of patients with refractory temporal lobe epilepsy.For the recruited patients with refractory TLE (Temporal Lobe Epilepsy), they will undergo a 6-week treatment with tACS (transcranial alternating current stimulation) protocol (2mA, 10Hz, 20 minutes per side), following a schedule of treatment for 5 days - rest for 2 days - treatment for another 5 days, and then a reinforcement treatment once a week, completing a total of 14 treatments.Before treatment, at week 10, and at week 14, the frequency of epileptic seizures and the QOLIE-31 questionnaire scores will be recorded and assessed for the patients. EEG data and near-infrared spectroscopy (NIRS) brain functional imaging data will be collected before treatment and after two consecutive weeks of treatment. Magnetic resonance imaging (MRI) data will be acquired before treatment, after two consecutive weeks of treatment, and after six weeks of intensified treatment. Appropriate image processing methods and EEG processing methods will be utilized to analyze the changes in brain networks following tACS treatment, in order to explore the impact of tACS on the neural mechanisms of refractory temporal lobe epilepsy (TLE).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years old;
- •Diagnosed with refractory temporal lobe epilepsy as defined by the International League Against Epilepsy (ILAE) (failure to achieve seizure-free status after adequate trials of two appropriate antiepileptic drugs);
- •Duration of epilepsy is at least 2 years, with a seizure frequency of at least 2 times per 4 weeks in the three months before enrollment;
- •Taking two or more antiepileptic drugs, and continuing the same medication treatment plan during the trial period;
- •Capable of cooperating to complete the treatment and related examination items;
- •The patient and family members fully understand and voluntarily sign the informed consent form.
排除标准
- •Scalp skin damage (including skin diseases or damage in the area where electrodes are applied);
- •Psychogenic epilepsy or pseudo-epilepsy;
- •Concurrent severe infections, cerebrovascular diseases, malignant tumors, or other diseases with severe dysfunction of major organs such as the heart, liver, and kidneys, or with mental disorders;
- •Presence of any implanted devices or instruments (such as cardiac pacemakers, deep brain stimulators, cochlear implants, and vagus nerve stimulators, etc.);
- •History of head trauma or other brain-related diseases;
- •Pregnant or breastfeeding women;
- •Participation in other clinical trials at the same time;
- •Changes in medication treatment plan during baseline, treatment, or follow-up period;
- •Withdrawal of informed consent by the patient or family members.
结局指标
主要结局
Compared to baseline, the reduction rate of epileptic seizure frequency
时间窗: baseline, 10 weeks,14 weeks after treatment
((post-treatment - baseline) / baseline).
次要结局
- Quality of Life in Epilepsy-31 (QOLIE-31) Questionnaire(baseline, 10 weeks,14 weeks after treatment)
- Near-Infrared Spectroscopy (NIRS) Brain Functional Imaging(baseline，2weeks after treatment)
- MRI measures(baseline，2weeks，14weeks after treatment)
- electroencephalogram(EEG)(baseline，2weeks after treatment)