Extreme Capsule Electrical Stimulation for Drug-resistant Focal Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Seizure frequency (SF28)
研究概览
简要总结
Evaluation of the Efficacy and Safety of Deep Brain Stimulation of the Extreme Capsule (EC) for the Treatment of Drug-Resistant Epilepsy
详细描述
This studyTo evaluate the efficacy and safety of deep brain stimulation of the EC for the treatment of drug-resistant epilepsy originating from EC structurally connected cortex cortex, This study aims to explore stimulation patterns and parameters that can suppress abnormal epileptic discharges at the seizure focus without impairing language function. This study aims to improve treatment challenges for these patients and promote clinical translation and application
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
- 14 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are between the ages of 14 -65 years of age
- •Diagnosis of drug-resistant epilepsy follows the standard of resistance to regular medication treatment for at least two years. Comprehensive preoperative epilepsy assessment, combined with individualized fiber tracking, is used to determine whether the epileptogenic zone is located in cortex regions structurally connected to the extreme capsule.
- •Persistence of disabling seizures at least 3 times per month or greater,
- •Informed consent signed.
排除标准
- •Structural alterations are present in the extreme capsule.
- •Diagnosed with generalized or hereditary epilepsy with ion channel gene mutations;
- •Psychogenic non-epileptic seizures within 12 months;
- •Presence of implanted electrical stimulation medical device anywhere in the body (e.g., pacemaker, spinal cord stimulator, responsive neurostimulation) or any metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagal nerve stimulators are allowed if the parameter remains stable for at least 3 months prior to the screening visit;
- •Risk factors that would put the participant at risk for intraoperative or postoperative bleeding. (e.g., coagulation abnormalities, etc.) or the need for chronic anticoagulation or antiplatelet aggregation medications;
- •IQ < 55 or severe cognitive dysfunction, unable to complete the study;
- •Diagnosed with a progressive neurological disorder (including progressive Rasmussen's encephalitis, etc.);
- •Diagnosed with a severe neuropsychiatric disorder such as dementia, major depression (admission to a psychiatric specialty/hospital within 5 years or any suicidal or self-injurious tendencies), schizophrenia, or neurodegenerative disorders;
- •Diagnosed with other serious physical disorders, internal diseases or severe abnormalities in liver or kidney function;
- •Pregnant, or planning to pregnant within 2 years;
- •Participation in another clinical study within 3 months;
- •Not suitable for enrollment as assessed by the multidisciplinary team of the center.
结局指标
主要结局
Seizure frequency (SF28)
时间窗: Up to 1 year after EC-DBS
Seizure frequency (SF28) is defined as seizure count per month (28-day) period. The SF28 is calculated as follows, where D=total number of days for which seizure information is collected for the specific 28-day interval: SF28=(Total number of seizures in D days/D)\*28. In addition, the baseline seizure frequency is defined as mean of 3-month SF28 in the baseline period. The seizure frequency in double-blind phase is defined as SF28 per month during the double-blind period. Percent change in seizure frequency=100\*(double-blind SF28-baseline SF28)/baseline SF28.
次要结局
- Seizure Responder Rate(Up to 1 year after EC-DBS)
- Life quality evaluation(Up to 1 year after EC-DBS)
- Adverse Events(Up to 1 year after EC-DBS)
- Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)(Up to 1 year after EC-DBS)
研究者
Liankun_Ren
Professor
Xuanwu Hospital, Beijing