Hippocampal and Thalamic Deep Brain Stimulation for Bilateral Temporal Lobe Epilepsy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Seizure Frequency
研究概览
简要总结
The study aims to compare the safety and effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for reducing the frequency of seizures in patients with bilateral temporal lobe epilepsy.
详细描述
The outcome of resective surgery for bilateral temporal lobe epilepsy (BTLE) is poor. Neuromodulation such as deep brain stimulation is an alternative therapy for patients with drug-resistant epilepsy, especially for those not suitable for resective surgery. This prospective, randomized, open-label trial aims to compare the effectiveness of deep brain stimulation of the hippocampus and the anterior nucleus of the thalamus for bilateral temporal lobe epilepsy.
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
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 12 to 60 years old.
- •Bilateral temporal lobe epilepsy patients proved by VEEG or SEEG.
- •At least 3 seizures per month but not more than 10 seizures per month, and the longest seizure interval is no more than 30 days during the baseline.
- •Patients failed to at least 3 antiepileptic drugs (AEDs), and are receiving at least 1 AEDs now.
- •Be able to complete seizure diary.
- •Agree to participate this study and sign informed consent.
排除标准
- •Extratemporal lobe epilepsy or with potential extratemporal epileptogenic focus.
- •Patients with psychogenic non-epileptic seizures.
- •IQ < 70, or unable to complete the study.
- •Patients are pregnant or plan for it.
- •Patients with implanted electrical stimulation medical device.
- •Patients with other severe neuropsychiatric disorders such as dementia, schizophrenia, or neurodegenerative diseases.
- •Patients with cerebral lesions which unsuitable for lead implantation.
研究组 & 干预措施
stimulation on the hippocampus
deep brain stimulation on the hippocampus
干预措施: deep brain stimulation (Device)
stimulation on the anterior nucleus of the thalamus
deep brain stimulation on the anterior nucleus of the thalamus
干预措施: deep brain stimulation (Device)
结局指标
主要结局
Change in Seizure Frequency
时间窗: 3 years after DBS
The seizure frequency after DBS compared to the seizure frequency in baseline.
Seizure-Free Rate
时间窗: 3 years after DBS
The rate of patients who achieve seizure free after DBS. Patients don't have seizure for at least 1 year are considered seizure free.
Responder Rate
时间窗: 3 years after DBS
The rate of patients response to DBS, patients have at least 50% decrease in average seizure frequency after DBS are considered as responder.
次要结局
- Change in Percentage of Seizure-free Days(1 year and 3 years after DBS)
- Change in the Maximum Length of Seizure Intervals(1 year and 3 years after DBS)
- Change in GTCS Frequency(1 year and 3 years after DBS)
- Incidence Rate of Sudden Unexplained Death in Epilepsy (SUDEP)(1 year and 3 years after DBS)
- Change in Memory(1 year and 3 years after DBS)
- Change in Cognitive Function(1 year and 3 years after DBS)
- Change in Depression(1 year and 3 years after DBS)