Clinical Trial of SEEG for Drug-resistant Epilepsy (SEEG-DRE)
A Clinical Trial Evaluating the Safety and Efficacy of Stereoelectroencephalography (SEEG) Electrode Combined With Radiofrequency Lesion System for the Treatment of Drug-Resistant Epilepsy
This trial evaluates the safety and efficacy of SEEG recording and functional mapping for patients with drug-resistant epilepsy. It also assesses the safety and therapeutic effectiveness of SEEG-guided radiofrequency ablation for this patient group. The study will collect clinical evidence to support the standardized application of this combined diagnostic and treatment workflow for drug-resistant epilepsy.
研究概览
详细说明
Stereoelectroencephalography (SEEG) is a minimally invasive presurgical evaluation modality for epilepsy. Intracranial electrodes are implanted using stereotactic techniques to record intracranial electroencephalographic (EEG) activity and deliver direct electrical stimulation, with the aim of delineating the epileptogenic zone in patients with focal epilepsy. Based on SEEG findings, clinicians can achieve highly precise localization of the epileptogenic zone and tailored surgical planning, or directly utilize SEEG-guided radiofrequency thermocoagulation (SEEG RF-TC) as an independent therapeutic intervention.
This study adopts a single-arm target-value design with a planned enrollment of 99 patients. All enrolled participants will undergo SEEG electrode implantation, followed by continuous SEEG monitoring for EEG recording and comprehensive presurgical evaluation. Eligible patients will then receive SEEG-guided radiofrequency thermocoagulation treatment. The primary efficacy endpoints include the success rate of intracranial EEG signal recording and the therapeutic response rate of thermocoagulation.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jiangguang Sun, DR.
- 电话号码：010-60736388
- 邮箱：sunjianguang@pinsmedical.com
研究联系人备份
- 姓名：Qqingshan Cui
- 电话号码：+86 18301287025
- 邮箱：cuiqingshan@pinsmedical.com
学习地点
-
-
-
Beijing、中国、100070
- Beijing Tiantan Hospital, Capital Medical University
-
接触：
- Kai Zhang
- 邮箱：zhangkai62035@sina.com
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100853
- Chinese PLA General Hospital
-
接触：
- Hulin Zhao
- 邮箱：zhaohulin_90@sohu.com
-
Beijing、Beijing Municipality、中国、100034
- Peking University First Hospital
-
接触：
- Ye Wu
- 邮箱：dryewu@bjmu.edu.cn
-
Beijing、Beijing Municipality、中国、100020
- Beijing Chaoyang Hospital
-
接触：
- Changqing Liu
- 邮箱：15101064296@163.com
-
Beijing、Beijing Municipality、中国、100043
- Xuanwu Hospital
-
接触：
- Yongzhi Shan
- 邮箱：shanyongzhi@xwhosp.org
-
-
Chongqing Municipality
-
Chongqing、Chongqing Municipality、中国、400037
- Second Affiliated Hospital of Army Medical University
-
Chongqing、Chongqing Municipality、中国、400010
- The second affiliated hospital of Chongqing medical university
-
接触：
- Yangmei Chen
- 邮箱：chenym1997@sina.com
-
接触：
- Feng Wang
- 邮箱：fengfly1984@163.com
-
-
Fujian
-
Fuzhou、Fujian、中国、350004
- First Affiliated Hospital of Fujian Medical University
-
接触：
- Yuanxiang Lin
- 邮箱：lyx99070@163.com
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510260
- Zhujiang Hospital of Southern Medical University
-
接触：
- Yanwu Guo
- 邮箱：dguoyanwu@163.com
-
Guangzhou、Guangdong、中国、510623
- Guangzhou women and children's medical center
-
接触：
- Ye Song
- 邮箱：songye0724@126.com
-
-
Heilongjiang
-
Harbin、Heilongjiang、中国、150086
- The Second Affiliated Hospital of Harbin Medical University
-
接触：
- Jinquan Cai
- 邮箱：sun978675@163.com
-
-
Hubei
-
Wuhan、Hubei、中国、430030
- Tongji Hospital Affiliated to Tongji Medical College of HUST
-
接触：
- Feng Hu
- 邮箱：527044115@qq.com
-
Wuhan、Hubei、中国、30014
- Central Theater Command General Hospital of Chinese People's Liberation Army
-
接触：
- Jian Song
- 邮箱：songjian0505@smu.edu.cn
-
-
Hunan
-
Changsha、Hunan、中国、410028
- Xiangya Hospital of Central South University
-
接触：
- Dingyang Liu
- 邮箱：Chshldy@csu.edu.cn
-
-
Shandong
-
Jinan、Shandong、中国、250012
- Qilu Hospital of Shandong University
-
接触：
- Shuo Xu
- 邮箱：xushuo@sdu.edu.cn
-
-
Xinjiang
-
Ürümqi、Xinjiang、中国、630000
- The First Affiliated Hospital of Xinjiang Medical University
-
接触：
- Lei Jiang
- 邮箱：jiangleidr@126.com
-
接触：
- Dengfeng Han
- 邮箱：32193860@qq.com
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
接触：
- Junming Zhu
- 邮箱：dr.zhujunming@zju.edu.cn
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age ≥ 2 years old and ≤ 70 years old, of any sex;
- Prior confirmed diagnosis of drug-resistant epilepsy (DRE);
- Mean epilepsy seizure frequency ≥ 1 episode per month in the 3 months preceding screening;
- Patients scheduled to undergo stereoelectroencephalography (SEEG) recording and RF thermocoagulation (RF-TC);
- The subject or their legal representative is capable of understanding the trial purpose, demonstrates sufficient adherence to the study protocol, and has provided signed informed consent;
Exclusion Criteria:
- Patients with contraindications to MRI;
- Patients with coagulation dysfunction or known coagulopathy;
- Women who are pregnant, planning pregnancy within 6 months, or breastfeeding;
- Patients with known hypersensitivity to any electrode material;
- Patients with contraindications to neurosurgical procedures;
- Subjects who have participated in any other investigational drug or medical device clinical trial within 3 months preceding screening;
- Subjects with severe cardiac, hepatic, or renal impairment who, in the investigator's judgment, are unsuitable for participation in this clinical investigation;
- Subjects who, in the investigator's judgment, demonstrate poor compliance or are unable to complete the study as required;
- Any other condition that, in the investigator's opinion, would render the subject unsuitable for participation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：single arm
Participants in this trial will undergo SEEG electrode implantation followed by SEEG recording and mapping, and will complete SEEG radiofrequency thermocoagulation (RF-TC). |
The patient will undergo SEEG-guided radiofrequency thermocoagulation (RF-TC). The procedure includes: electrode implantation, EEG recording, SEEG RF-TC, and electrode extraction.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
SEEG Recording Success Rate
大体时间：Within 30 days after implantation of electrodes
|
The proportion of patients achieving successful SEEG recording |
Within 30 days after implantation of electrodes
|
|
RF-TC Efficacy Rate
大体时间：Within 3 days after RF-TC
|
The proportion of patients achieving successful RF-TC.RF lesion measured on the post-procedural brain MRI. |
Within 3 days after RF-TC
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Electrode Placement Accuracy
大体时间：Within 30 days after implantation of electrodes
|
co-registering the pre-operative surgical plan and post-op CT，calculate the error between the actual placement position of the electrode and the surgical plan at the skull entry point and the target point.Measuring unit: mm. |
Within 30 days after implantation of electrodes
|
|
Technical success rate of RF-TC
大体时间：During RF-TC operation
|
Medical recording |
During RF-TC operation
|
|
Vital signs-body temperature
大体时间：baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-pulse
大体时间：baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-respiratory rate
大体时间：baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-blood pressure
大体时间：baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
the reduction rate of spike frequency after RF-TC
大体时间：Periprocedural of RF-TC
|
SEEG recording |
Periprocedural of RF-TC
|
|
Questionnaire of Device Performance Evaluation
大体时间：immediately after the procedure/surgery
|
a 5-level scale used to evaluate the Device Performance |
immediately after the procedure/surgery
|
|
Seizure reduction rate
大体时间：90±7 days after RF-TC
|
Follow up |
90±7 days after RF-TC
|
|
Mini-Mental State Examination (MMSE) score
大体时间：Before and 90±7 days after RF-TC
|
Lower score indicates worse cognitive impairment |
Before and 90±7 days after RF-TC
|
|
Quality of life in epilepsy-31 inventory (QOLIE-31) score
大体时间：Before and 90±7 days after RF-TC
|
For adult; Higher scores correspond to better health-related quality of life |
Before and 90±7 days after RF-TC
|
|
Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score
大体时间：Before and 90±7 days after RF-TC
|
For Adolescents; Higher scores correspond to better health-related quality of life |
Before and 90±7 days after RF-TC
|
|
child epilepsy questionnnaire-parental form
大体时间：Before and 90±7 days after RF-TC
|
For children; Higher scores correspond to better health-related quality of life |
Before and 90±7 days after RF-TC
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of adverse events and serious adverse events
大体时间：through study completion, an average of 5 months
|
Medical recording |
through study completion, an average of 5 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.