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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jiangguang Sun, DR.
- Numéro de téléphone: 010-60736388
- E-mail: sunjianguang@pinsmedical.com
Sauvegarde des contacts de l'étude
- Nom: Qqingshan Cui
- Numéro de téléphone: +86 18301287025
- E-mail: cuiqingshan@pinsmedical.com
Lieux d'étude
-
-
-
Beijing, Chine, 100070
- Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Kai Zhang
- E-mail: zhangkai62035@sina.com
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Chine, 100853
- Chinese PLA General Hospital
-
Contact:
- Hulin Zhao
- E-mail: zhaohulin_90@sohu.com
-
Beijing, Beijing Municipality, Chine, 100034
- Peking University First Hospital
-
Contact:
- Ye Wu
- E-mail: dryewu@bjmu.edu.cn
-
Beijing, Beijing Municipality, Chine, 100020
- Beijing Chaoyang Hospital
-
Contact:
- Changqing Liu
- E-mail: 15101064296@163.com
-
Beijing, Beijing Municipality, Chine, 100043
- Xuanwu Hospital
-
Contact:
- Yongzhi Shan
- E-mail: shanyongzhi@xwhosp.org
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Chine, 400037
- Second Affiliated Hospital of Army Medical University
-
Chongqing, Chongqing Municipality, Chine, 400010
- The second affiliated hospital of Chongqing medical university
-
Contact:
- Yangmei Chen
- E-mail: chenym1997@sina.com
-
Contact:
- Feng Wang
- E-mail: fengfly1984@163.com
-
-
Fujian
-
Fuzhou, Fujian, Chine, 350004
- First Affiliated Hospital of Fujian Medical University
-
Contact:
- Yuanxiang Lin
- E-mail: lyx99070@163.com
-
-
Guangdong
-
Guangzhou, Guangdong, Chine, 510260
- Zhujiang Hospital of Southern Medical University
-
Contact:
- Yanwu Guo
- E-mail: dguoyanwu@163.com
-
Guangzhou, Guangdong, Chine, 510623
- Guangzhou women and children's medical center
-
Contact:
- Ye Song
- E-mail: songye0724@126.com
-
-
Heilongjiang
-
Harbin, Heilongjiang, Chine, 150086
- The Second Affiliated Hospital of Harbin Medical University
-
Contact:
- Jinquan Cai
- E-mail: sun978675@163.com
-
-
Hubei
-
Wuhan, Hubei, Chine, 430030
- Tongji Hospital Affiliated to Tongji Medical College of HUST
-
Contact:
- Feng Hu
- E-mail: 527044115@qq.com
-
Wuhan, Hubei, Chine, 30014
- Central Theater Command General Hospital of Chinese People's Liberation Army
-
Contact:
- Jian Song
- E-mail: songjian0505@smu.edu.cn
-
-
Hunan
-
Changsha, Hunan, Chine, 410028
- Xiangya Hospital of Central South University
-
Contact:
- Dingyang Liu
- E-mail: Chshldy@csu.edu.cn
-
-
Shandong
-
Jinan, Shandong, Chine, 250012
- Qilu Hospital of Shandong University
-
Contact:
- Shuo Xu
- E-mail: xushuo@sdu.edu.cn
-
-
Xinjiang
-
Ürümqi, Xinjiang, Chine, 630000
- The First Affiliated Hospital of Xinjiang Medical University
-
Contact:
- Lei Jiang
- E-mail: jiangleidr@126.com
-
Contact:
- Dengfeng Han
- E-mail: 32193860@qq.com
-
-
Zhejiang
-
Hangzhou, Zhejiang, Chine, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
-
Contact:
- Junming Zhu
- E-mail: dr.zhujunming@zju.edu.cn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
SEEG Recording Success Rate
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Electrode Placement Accuracy
Délai: 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
Délai: During RF-TC operation
|
Medical recording |
During RF-TC operation
|
|
Vital signs-body temperature
Délai: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-pulse
Délai: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-respiratory rate
Délai: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-blood pressure
Délai: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
the reduction rate of spike frequency after RF-TC
Délai: Periprocedural of RF-TC
|
SEEG recording |
Periprocedural of RF-TC
|
|
Questionnaire of Device Performance Evaluation
Délai: immediately after the procedure/surgery
|
a 5-level scale used to evaluate the Device Performance |
immediately after the procedure/surgery
|
|
Seizure reduction rate
Délai: 90±7 days after RF-TC
|
Follow up |
90±7 days after RF-TC
|
|
Mini-Mental State Examination (MMSE) score
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of adverse events and serious adverse events
Délai: through study completion, an average of 5 months
|
Medical recording |
through study completion, an average of 5 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SLXX(X)&PINS-C2-01-53
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .