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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jiangguang Sun, DR.
- 電話番号：010-60736388
- メール：sunjianguang@pinsmedical.com
研究連絡先のバックアップ
- 名前：Qqingshan Cui
- 電話番号：+86 18301287025
- メール：cuiqingshan@pinsmedical.com
研究場所
-
-
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Beijing、中国、100070
- Beijing Tiantan Hospital, Capital Medical University
-
コンタクト：
- Kai Zhang
- メール：zhangkai62035@sina.com
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100853
- Chinese PLA General Hospital
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コンタクト：
- Hulin Zhao
- メール：zhaohulin_90@sohu.com
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Beijing、Beijing Municipality、中国、100034
- Peking University First Hospital
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コンタクト：
- Ye Wu
- メール：dryewu@bjmu.edu.cn
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Beijing、Beijing Municipality、中国、100020
- Beijing Chaoyang Hospital
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コンタクト：
- Changqing Liu
- メール：15101064296@163.com
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Beijing、Beijing Municipality、中国、100043
- Xuanwu Hospital
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コンタクト：
- Yongzhi Shan
- メール：shanyongzhi@xwhosp.org
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400037
- Second Affiliated Hospital of Army Medical University
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Chongqing、Chongqing Municipality、中国、400010
- The second affiliated hospital of Chongqing medical university
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コンタクト：
- Yangmei Chen
- メール：chenym1997@sina.com
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コンタクト：
- Feng Wang
- メール：fengfly1984@163.com
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Fujian
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Fuzhou、Fujian、中国、350004
- First Affiliated Hospital of Fujian Medical University
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コンタクト：
- Yuanxiang Lin
- メール：lyx99070@163.com
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Guangdong
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Guangzhou、Guangdong、中国、510260
- Zhujiang Hospital of Southern Medical University
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コンタクト：
- Yanwu Guo
- メール：dguoyanwu@163.com
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Guangzhou、Guangdong、中国、510623
- Guangzhou women and children's medical center
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コンタクト：
- Ye Song
- メール：songye0724@126.com
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Heilongjiang
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Harbin、Heilongjiang、中国、150086
- The Second Affiliated Hospital of Harbin Medical University
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コンタクト：
- Jinquan Cai
- メール：sun978675@163.com
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Hubei
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Wuhan、Hubei、中国、430030
- Tongji Hospital Affiliated to Tongji Medical College of HUST
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コンタクト：
- Feng Hu
- メール：527044115@qq.com
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Wuhan、Hubei、中国、30014
- Central Theater Command General Hospital of Chinese People's Liberation Army
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コンタクト：
- Jian Song
- メール：songjian0505@smu.edu.cn
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Hunan
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Changsha、Hunan、中国、410028
- Xiangya Hospital of Central South University
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コンタクト：
- Dingyang Liu
- メール：Chshldy@csu.edu.cn
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Shandong
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Jinan、Shandong、中国、250012
- Qilu Hospital of Shandong University
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コンタクト：
- Shuo Xu
- メール：xushuo@sdu.edu.cn
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Xinjiang
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Ürümqi、Xinjiang、中国、630000
- The First Affiliated Hospital of Xinjiang Medical University
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コンタクト：
- Lei Jiang
- メール：jiangleidr@126.com
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コンタクト：
- Dengfeng Han
- メール：32193860@qq.com
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Zhejiang
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Hangzhou、Zhejiang、中国、310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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コンタクト：
- Junming Zhu
- メール：dr.zhujunming@zju.edu.cn
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SEEG Recording Success Rate
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Electrode Placement Accuracy
時間枠：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
時間枠：During RF-TC operation
|
Medical recording |
During RF-TC operation
|
|
Vital signs-body temperature
時間枠：baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-pulse
時間枠：baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-respiratory rate
時間枠：baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-blood pressure
時間枠：baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
the reduction rate of spike frequency after RF-TC
時間枠：Periprocedural of RF-TC
|
SEEG recording |
Periprocedural of RF-TC
|
|
Questionnaire of Device Performance Evaluation
時間枠：immediately after the procedure/surgery
|
a 5-level scale used to evaluate the Device Performance |
immediately after the procedure/surgery
|
|
Seizure reduction rate
時間枠：90±7 days after RF-TC
|
Follow up |
90±7 days after RF-TC
|
|
Mini-Mental State Examination (MMSE) score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of adverse events and serious adverse events
時間枠：through study completion, an average of 5 months
|
Medical recording |
through study completion, an average of 5 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。