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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Jiangguang Sun, DR.
- Telefonnummer: 010-60736388
- E-mail: sunjianguang@pinsmedical.com
Undersøgelse Kontakt Backup
- Navn: Qqingshan Cui
- Telefonnummer: +86 18301287025
- E-mail: cuiqingshan@pinsmedical.com
Studiesteder
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Beijing, Kina, 100070
- Beijing Tiantan Hospital, Capital Medical University
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Kontakt:
- Kai Zhang
- E-mail: zhangkai62035@sina.com
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100853
- Chinese PLA General Hospital
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Kontakt:
- Hulin Zhao
- E-mail: zhaohulin_90@sohu.com
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Beijing, Beijing Municipality, Kina, 100034
- Peking University First Hospital
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Kontakt:
- Ye Wu
- E-mail: dryewu@bjmu.edu.cn
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Beijing, Beijing Municipality, Kina, 100020
- Beijing Chaoyang Hospital
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Kontakt:
- Changqing Liu
- E-mail: 15101064296@163.com
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Beijing, Beijing Municipality, Kina, 100043
- Xuanwu Hospital
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Kontakt:
- Yongzhi Shan
- E-mail: shanyongzhi@xwhosp.org
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400037
- Second Affiliated Hospital of Army Medical University
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Chongqing, Chongqing Municipality, Kina, 400010
- The second affiliated hospital of Chongqing medical university
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Kontakt:
- Yangmei Chen
- E-mail: chenym1997@sina.com
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Kontakt:
- Feng Wang
- E-mail: fengfly1984@163.com
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Fujian
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Fuzhou, Fujian, Kina, 350004
- First Affiliated Hospital of Fujian Medical University
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Kontakt:
- Yuanxiang Lin
- E-mail: lyx99070@163.com
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Guangdong
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Guangzhou, Guangdong, Kina, 510260
- Zhujiang Hospital of Southern Medical University
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Kontakt:
- Yanwu Guo
- E-mail: dguoyanwu@163.com
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Guangzhou, Guangdong, Kina, 510623
- Guangzhou women and children's medical center
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Kontakt:
- Ye Song
- E-mail: songye0724@126.com
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150086
- The Second Affiliated Hospital of Harbin Medical University
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Kontakt:
- Jinquan Cai
- E-mail: sun978675@163.com
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Hubei
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Wuhan, Hubei, Kina, 430030
- Tongji Hospital Affiliated to Tongji Medical College of HUST
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Kontakt:
- Feng Hu
- E-mail: 527044115@qq.com
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Wuhan, Hubei, Kina, 30014
- Central Theater Command General Hospital of Chinese People's Liberation Army
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Kontakt:
- Jian Song
- E-mail: songjian0505@smu.edu.cn
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Hunan
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Changsha, Hunan, Kina, 410028
- Xiangya Hospital of Central South University
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Kontakt:
- Dingyang Liu
- E-mail: Chshldy@csu.edu.cn
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Shandong
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Jinan, Shandong, Kina, 250012
- Qilu Hospital of Shandong University
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Kontakt:
- Shuo Xu
- E-mail: xushuo@sdu.edu.cn
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Xinjiang
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Ürümqi, Xinjiang, Kina, 630000
- The First Affiliated Hospital of Xinjiang Medical University
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Kontakt:
- Lei Jiang
- E-mail: jiangleidr@126.com
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Kontakt:
- Dengfeng Han
- E-mail: 32193860@qq.com
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Kontakt:
- Junming Zhu
- E-mail: dr.zhujunming@zju.edu.cn
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
SEEG Recording Success Rate
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Electrode Placement Accuracy
Tidsramme: 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
Tidsramme: During RF-TC operation
|
Medical recording |
During RF-TC operation
|
|
Vital signs-body temperature
Tidsramme: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-pulse
Tidsramme: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-respiratory rate
Tidsramme: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-blood pressure
Tidsramme: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
the reduction rate of spike frequency after RF-TC
Tidsramme: Periprocedural of RF-TC
|
SEEG recording |
Periprocedural of RF-TC
|
|
Questionnaire of Device Performance Evaluation
Tidsramme: immediately after the procedure/surgery
|
a 5-level scale used to evaluate the Device Performance |
immediately after the procedure/surgery
|
|
Seizure reduction rate
Tidsramme: 90±7 days after RF-TC
|
Follow up |
90±7 days after RF-TC
|
|
Mini-Mental State Examination (MMSE) score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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child epilepsy questionnnaire-parental form
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of adverse events and serious adverse events
Tidsramme: through study completion, an average of 5 months
|
Medical recording |
through study completion, an average of 5 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SLXX(X)&PINS-C2-01-53
Plan for individuelle deltagerdata (IPD)
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