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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Jiangguang Sun, DR.
- Telefoonnummer: 010-60736388
- E-mail: sunjianguang@pinsmedical.com
Studie Contact Back-up
- Naam: Qqingshan Cui
- Telefoonnummer: +86 18301287025
- E-mail: cuiqingshan@pinsmedical.com
Studie Locaties
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Beijing, China, 100070
- Beijing Tiantan Hospital, Capital Medical University
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Contact:
- Kai Zhang
- E-mail: zhangkai62035@sina.com
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100853
- Chinese PLA General Hospital
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Contact:
- Hulin Zhao
- E-mail: zhaohulin_90@sohu.com
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Beijing, Beijing Municipality, China, 100034
- Peking University First Hospital
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Contact:
- Ye Wu
- E-mail: dryewu@bjmu.edu.cn
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Beijing, Beijing Municipality, China, 100020
- Beijing Chaoyang Hospital
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Contact:
- Changqing Liu
- E-mail: 15101064296@163.com
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Beijing, Beijing Municipality, China, 100043
- Xuanwu Hospital
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Contact:
- Yongzhi Shan
- E-mail: shanyongzhi@xwhosp.org
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400037
- Second Affiliated Hospital of Army Medical University
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Chongqing, Chongqing Municipality, China, 400010
- The second affiliated hospital of Chongqing medical university
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Contact:
- Yangmei Chen
- E-mail: chenym1997@sina.com
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Contact:
- Feng Wang
- E-mail: fengfly1984@163.com
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Fujian
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Fuzhou, Fujian, China, 350004
- First Affiliated Hospital of Fujian Medical University
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Contact:
- Yuanxiang Lin
- E-mail: lyx99070@163.com
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Guangdong
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Guangzhou, Guangdong, China, 510260
- Zhujiang Hospital of Southern Medical University
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Contact:
- Yanwu Guo
- E-mail: dguoyanwu@163.com
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Guangzhou, Guangdong, China, 510623
- Guangzhou women and children's medical center
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Contact:
- Ye Song
- E-mail: songye0724@126.com
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Heilongjiang
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Harbin, Heilongjiang, China, 150086
- The Second Affiliated Hospital of Harbin Medical University
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Contact:
- Jinquan Cai
- E-mail: sun978675@163.com
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital Affiliated to Tongji Medical College of HUST
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Contact:
- Feng Hu
- E-mail: 527044115@qq.com
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Wuhan, Hubei, China, 30014
- Central Theater Command General Hospital of Chinese People's Liberation Army
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Contact:
- Jian Song
- E-mail: songjian0505@smu.edu.cn
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Hunan
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Changsha, Hunan, China, 410028
- Xiangya Hospital of Central South University
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Contact:
- Dingyang Liu
- E-mail: Chshldy@csu.edu.cn
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Shandong
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Jinan, Shandong, China, 250012
- Qilu Hospital of Shandong University
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Contact:
- Shuo Xu
- E-mail: xushuo@sdu.edu.cn
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Xinjiang
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Ürümqi, Xinjiang, China, 630000
- The First Affiliated Hospital of Xinjiang Medical University
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Contact:
- Lei Jiang
- E-mail: jiangleidr@126.com
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Contact:
- Dengfeng Han
- E-mail: 32193860@qq.com
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Contact:
- Junming Zhu
- E-mail: dr.zhujunming@zju.edu.cn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
SEEG Recording Success Rate
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Electrode Placement Accuracy
Tijdsspanne: 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
Tijdsspanne: During RF-TC operation
|
Medical recording |
During RF-TC operation
|
|
Vital signs-body temperature
Tijdsspanne: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
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Vital signs-pulse
Tijdsspanne: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-respiratory rate
Tijdsspanne: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
Vital signs-blood pressure
Tijdsspanne: baseline, Perioperative
|
From medical recording |
baseline, Perioperative
|
|
the reduction rate of spike frequency after RF-TC
Tijdsspanne: Periprocedural of RF-TC
|
SEEG recording |
Periprocedural of RF-TC
|
|
Questionnaire of Device Performance Evaluation
Tijdsspanne: immediately after the procedure/surgery
|
a 5-level scale used to evaluate the Device Performance |
immediately after the procedure/surgery
|
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Seizure reduction rate
Tijdsspanne: 90±7 days after RF-TC
|
Follow up |
90±7 days after RF-TC
|
|
Mini-Mental State Examination (MMSE) score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of adverse events and serious adverse events
Tijdsspanne: through study completion, an average of 5 months
|
Medical recording |
through study completion, an average of 5 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SLXX(X)&PINS-C2-01-53
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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