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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jiangguang Sun, DR.
- 전화번호: 010-60736388
- 이메일: sunjianguang@pinsmedical.com
연구 연락처 백업
- 이름: Qqingshan Cui
- 전화번호: +86 18301287025
- 이메일: cuiqingshan@pinsmedical.com
연구 장소
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Beijing, 중국, 100070
- Beijing Tiantan Hospital, Capital Medical University
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연락하다:
- Kai Zhang
- 이메일: zhangkai62035@sina.com
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100853
- Chinese PLA General Hospital
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연락하다:
- Hulin Zhao
- 이메일: zhaohulin_90@sohu.com
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Beijing, Beijing Municipality, 중국, 100034
- Peking University First Hospital
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연락하다:
- Ye Wu
- 이메일: dryewu@bjmu.edu.cn
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Beijing, Beijing Municipality, 중국, 100020
- Beijing Chaoyang Hospital
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연락하다:
- Changqing Liu
- 이메일: 15101064296@163.com
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Beijing, Beijing Municipality, 중국, 100043
- Xuanwu Hospital
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연락하다:
- Yongzhi Shan
- 이메일: shanyongzhi@xwhosp.org
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Chongqing Municipality
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Chongqing, Chongqing Municipality, 중국, 400037
- Second Affiliated Hospital of Army Medical University
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Chongqing, Chongqing Municipality, 중국, 400010
- The second affiliated hospital of Chongqing medical university
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연락하다:
- Yangmei Chen
- 이메일: chenym1997@sina.com
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연락하다:
- Feng Wang
- 이메일: fengfly1984@163.com
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Fujian
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Fuzhou, Fujian, 중국, 350004
- First Affiliated Hospital of Fujian Medical University
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연락하다:
- Yuanxiang Lin
- 이메일: lyx99070@163.com
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Guangdong
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Guangzhou, Guangdong, 중국, 510260
- Zhujiang Hospital of Southern Medical University
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연락하다:
- Yanwu Guo
- 이메일: dguoyanwu@163.com
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Guangzhou, Guangdong, 중국, 510623
- Guangzhou women and children's medical center
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연락하다:
- Ye Song
- 이메일: songye0724@126.com
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Heilongjiang
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Harbin, Heilongjiang, 중국, 150086
- The Second Affiliated Hospital of Harbin Medical University
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연락하다:
- Jinquan Cai
- 이메일: sun978675@163.com
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Hubei
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Wuhan, Hubei, 중국, 430030
- Tongji Hospital Affiliated to Tongji Medical College of HUST
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연락하다:
- Feng Hu
- 이메일: 527044115@qq.com
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Wuhan, Hubei, 중국, 30014
- Central Theater Command General Hospital of Chinese People's Liberation Army
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연락하다:
- Jian Song
- 이메일: songjian0505@smu.edu.cn
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Hunan
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Changsha, Hunan, 중국, 410028
- Xiangya Hospital of Central South University
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연락하다:
- Dingyang Liu
- 이메일: Chshldy@csu.edu.cn
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Shandong
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Jinan, Shandong, 중국, 250012
- Qilu Hospital of Shandong University
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연락하다:
- Shuo Xu
- 이메일: xushuo@sdu.edu.cn
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Xinjiang
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Ürümqi, Xinjiang, 중국, 630000
- The First Affiliated Hospital of Xinjiang Medical University
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연락하다:
- Lei Jiang
- 이메일: jiangleidr@126.com
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연락하다:
- Dengfeng Han
- 이메일: 32193860@qq.com
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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연락하다:
- Junming Zhu
- 이메일: dr.zhujunming@zju.edu.cn
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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SEEG Recording Success Rate
기간: Within 30 days after implantation of electrodes
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The proportion of patients achieving successful SEEG recording |
Within 30 days after implantation of electrodes
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RF-TC Efficacy Rate
기간: Within 3 days after RF-TC
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The proportion of patients achieving successful RF-TC.RF lesion measured on the post-procedural brain MRI. |
Within 3 days after RF-TC
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Electrode Placement Accuracy
기간: Within 30 days after implantation of electrodes
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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
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Technical success rate of RF-TC
기간: During RF-TC operation
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Medical recording |
During RF-TC operation
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Vital signs-body temperature
기간: baseline, Perioperative
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From medical recording |
baseline, Perioperative
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Vital signs-pulse
기간: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
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Vital signs-respiratory rate
기간: baseline, Perioperative
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From medical recording |
baseline, Perioperative
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Vital signs-blood pressure
기간: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
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the reduction rate of spike frequency after RF-TC
기간: Periprocedural of RF-TC
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SEEG recording |
Periprocedural of RF-TC
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Questionnaire of Device Performance Evaluation
기간: immediately after the procedure/surgery
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a 5-level scale used to evaluate the Device Performance |
immediately after the procedure/surgery
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Seizure reduction rate
기간: 90±7 days after RF-TC
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Follow up |
90±7 days after RF-TC
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Mini-Mental State Examination (MMSE) score
기간: Before and 90±7 days after RF-TC
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Lower score indicates worse cognitive impairment |
Before and 90±7 days after RF-TC
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Quality of life in epilepsy-31 inventory (QOLIE-31) score
기간: Before and 90±7 days after RF-TC
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For adult; Higher scores correspond to better health-related quality of life |
Before and 90±7 days after RF-TC
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Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score
기간: Before and 90±7 days after RF-TC
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For Adolescents; Higher scores correspond to better health-related quality of life |
Before and 90±7 days after RF-TC
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child epilepsy questionnnaire-parental form
기간: Before and 90±7 days after RF-TC
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For children; Higher scores correspond to better health-related quality of life |
Before and 90±7 days after RF-TC
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of adverse events and serious adverse events
기간: through study completion, an average of 5 months
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Medical recording |
through study completion, an average of 5 months
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공동 작업자 및 조사자
협력자
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SLXX(X)&PINS-C2-01-53
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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