Drug-Resistant EpilepsySEEG-DRENCT07923058
Clinical Trial of SEEG for Drug-resistant Epilepsy
A study testing SEEG RF-TC in people with Drug-Resistant Epilepsy, run by Beijing Pins Medical Co., Ltd at 17 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Drug-Resistant Epilepsy
- What is being tested?
- SEEG RF-TC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 17 sitesChina
- Study dates
- 23 Oct 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
China17 sites
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Changqing Liu, 15101064296@163.com
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Ye Wu, dryewu@bjmu.edu.cn
Xuanwu Hospital
Beijing, Beijing Municipality, 100043
Yongzhi Shan, shanyongzhi@xwhosp.org
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Hulin Zhao, zhaohulin_90@sohu.com
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Kai Zhang, zhangkai62035@sina.com
Xiangya Hospital of Central South University
Changsha, Hunan, 410028
Dingyang Liu, Chshldy@csu.edu.cn
The second affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, 400010
Yangmei Chen, chenym1997@sina.com
Feng Wang, fengfly1984@163.com
Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400037
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350004
Yuanxiang Lin, lyx99070@163.com
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510260
Yanwu Guo, dguoyanwu@163.com
Guangzhou women and children's medical center
Guangzhou, Guangdong, 510623
Ye Song, songye0724@126.com
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Junming Zhu, dr.zhujunming@zju.edu.cn
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Jinquan Cai, sun978675@163.com
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Shuo Xu, xushuo@sdu.edu.cn
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 630000
Lei Jiang, jiangleidr@126.com
Dengfeng Han, 32193860@qq.com
Central Theater Command General Hospital of Chinese People's Liberation Army
Wuhan, Hubei, 30014
Jian Song, songjian0505@smu.edu.cn
Tongji Hospital Affiliated to Tongji Medical College of HUST
Wuhan, Hubei, 430030
Feng Hu, 527044115@qq.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Drug-Resistant Epilepsy
- Being tested
- SEEG RF-TC
- Keywords
- SEEG, RF-TC
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEEG RF-TCProcedure or surgery
Also called SEEG-guided radiofrequency thermocoagulation
The patient will undergo SEEG-guided radiofrequency thermocoagulation (RF-TC). The procedure includes: electrode implantation, EEG recording, SEEG RF-TC, and electrode extraction.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Participants in this trial will undergo SEEG electrode implantation followed by SEEG recording and mapping, and will complete SEEG radiofrequency thermocoagulation (RF-TC). Receives: Procedure: SEEG RF-TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
SEEG Recording Success Rate
The proportion of patients achieving successful SEEG recording
Measured: Within 30 days after implantation of electrodes
RF-TC Efficacy Rate
The proportion of patients achieving successful RF-TC.RF lesion measured on the post-procedural brain MRI.
Measured: Within 3 days after RF-TC
Secondary outcomes (13)
Electrode Placement Accuracy
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.
Measured: Within 30 days after implantation of electrodes
Technical success rate of RF-TC
Medical recording
Measured: During RF-TC operation
Vital signs-body temperature
From medical recording
Measured: baseline, Perioperative
Vital signs-pulse
From medical recording
Measured: baseline, Perioperative
Vital signs-respiratory rate
From medical recording
Measured: baseline, Perioperative
Vital signs-blood pressure
From medical recording
Measured: baseline, Perioperative
the reduction rate of spike frequency after RF-TC
SEEG recording
Measured: Periprocedural of RF-TC
Questionnaire of Device Performance Evaluation
a 5-level scale used to evaluate the Device Performance
Measured: immediately after the procedure/surgery
Seizure reduction rate
Follow up
Measured: 90±7 days after RF-TC
Mini-Mental State Examination (MMSE) score
Lower score indicates worse cognitive impairment
Measured: Before and 90±7 days after RF-TC
Quality of life in epilepsy-31 inventory (QOLIE-31) score
For adult; Higher scores correspond to better health-related quality of life
Measured: Before and 90±7 days after RF-TC
Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score
For Adolescents; Higher scores correspond to better health-related quality of life
Measured: Before and 90±7 days after RF-TC
child epilepsy questionnnaire-parental form
For children; Higher scores correspond to better health-related quality of life
Measured: Before and 90±7 days after RF-TC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start23 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Neo Science Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923058
- Sponsor's protocol ID
- SLXX(X)&PINS-C2-01-53
- Acronym
- SEEG-DRE
- Status last verified
- Nov 2026
- First submitted
- 21 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Evaluating the Safety and Efficacy of Stereoelectroencephalography (SEEG) Electrode Combined With Radiofrequency Lesion System for the Treatment of Drug-Resistant Epilepsy
- ClinicalTrials.gov ID
- NCT07923058
- Acronym / sponsor ID
- SEEG-DRE / SLXX(X)&PINS-C2-01-53
- Conditions
- Drug-Resistant Epilepsy
- Keywords
- SEEG, RF-TC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Neo Science Co., Ltd.
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Procedure: SEEG RF-TCParticipants in this trial will undergo SEEG electrode implantation followed by SEEG recording and mapping, and will complete SEEG radiofrequency thermocoagulation (RF-TC). |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEEG RF-TCAlso: SEEG-guided radiofrequency thermocoagulationThe patient will undergo SEEG-guided radiofrequency thermocoagulation (RF-TC). The procedure includes: electrode implantation, EEG recording, SEEG RF-TC, and electrode extraction. | Procedure or surgery | single arm |
Primary outcome
SEEG Recording Success Rate
Time frame: Within 30 days after implantation of electrodes
The proportion of patients achieving successful SEEG recording
RF-TC Efficacy Rate
Time frame: Within 3 days after RF-TC
The proportion of patients achieving successful RF-TC.RF lesion measured on the post-procedural brain MRI.
13 secondary outcomes
Electrode Placement Accuracy
Time frame: Within 30 days after implantation of electrodes
Technical success rate of RF-TC
Time frame: During RF-TC operation
Vital signs-body temperature
Time frame: baseline, Perioperative
Vital signs-pulse
Time frame: baseline, Perioperative
Vital signs-respiratory rate
Time frame: baseline, Perioperative
Vital signs-blood pressure
Time frame: baseline, Perioperative
the reduction rate of spike frequency after RF-TC
Time frame: Periprocedural of RF-TC
Questionnaire of Device Performance Evaluation
Time frame: immediately after the procedure/surgery
Seizure reduction rate
Time frame: 90±7 days after RF-TC
Mini-Mental State Examination (MMSE) score
Time frame: Before and 90±7 days after RF-TC
Quality of life in epilepsy-31 inventory (QOLIE-31) score
Time frame: Before and 90±7 days after RF-TC
Quality of life in epilepsy for Adolescents (QOLIE-AD-48) score
Time frame: Before and 90±7 days after RF-TC
child epilepsy questionnnaire-parental form
Time frame: Before and 90±7 days after RF-TC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEEG RF-TC in people with Drug-Resistant Epilepsy, run by Beijing Pins Medical Co., Ltd at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiangguang Sun, DR. (010-60736388, sunjianguang@pinsmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SEEG Recording Success Rate (time frame: Within 30 days after implantation of electrodes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.