Clinical Trial of SEEG for Drug-resistant Epilepsy (SEEG-DRE)

November 3, 2026 updated by: Beijing Pins Medical Co., Ltd

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100070
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
      • Beijing, Beijing Municipality, China, 100034
      • Beijing, Beijing Municipality, China, 100020
      • Beijing, Beijing Municipality, China, 100043
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400037
        • Second Affiliated Hospital of Army Medical University
      • Chongqing, Chongqing Municipality, China, 400010
    • Fujian
      • Fuzhou, Fujian, China, 350004
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Zhujiang Hospital of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, China, 510623
        • Guangzhou women and children's medical center
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Affiliated to Tongji Medical College of HUST
        • Contact:
      • Wuhan, Hubei, China, 30014
        • Central Theater Command General Hospital of Chinese People's Liberation Army
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410028
        • Xiangya Hospital of Central South University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
    • Xinjiang
      • Ürümqi, Xinjiang, China, 630000
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 2 years old and ≤ 70 years old, of any sex;
  2. Prior confirmed diagnosis of drug-resistant epilepsy (DRE);
  3. Mean epilepsy seizure frequency ≥ 1 episode per month in the 3 months preceding screening;
  4. Patients scheduled to undergo stereoelectroencephalography (SEEG) recording and RF thermocoagulation (RF-TC);
  5. 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:

  1. Patients with contraindications to MRI;
  2. Patients with coagulation dysfunction or known coagulopathy;
  3. Women who are pregnant, planning pregnancy within 6 months, or breastfeeding;
  4. Patients with known hypersensitivity to any electrode material;
  5. Patients with contraindications to neurosurgical procedures;
  6. Subjects who have participated in any other investigational drug or medical device clinical trial within 3 months preceding screening;
  7. Subjects with severe cardiac, hepatic, or renal impairment who, in the investigator's judgment, are unsuitable for participation in this clinical investigation;
  8. Subjects who, in the investigator's judgment, demonstrate poor compliance or are unable to complete the study as required;
  9. Any other condition that, in the investigator's opinion, would render the subject unsuitable for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Procedure: SEEG 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.

Other Names:
  • SEEG-guided radiofrequency thermocoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SEEG Recording Success Rate
Time Frame: 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
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.
Within 3 days after RF-TC

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrode Placement Accuracy
Time Frame: 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
Time Frame: During RF-TC operation

Medical recording
During RF-TC operation
Vital signs-body temperature
Time Frame: baseline, Perioperative

From medical recording
baseline, Perioperative
Vital signs-pulse
Time Frame: baseline, Perioperative

From medical recording
baseline, Perioperative
Vital signs-respiratory rate
Time Frame: baseline, Perioperative

From medical recording
baseline, Perioperative
Vital signs-blood pressure
Time Frame: baseline, Perioperative

From medical recording
baseline, Perioperative
the reduction rate of spike frequency after RF-TC
Time Frame: Periprocedural of RF-TC

SEEG recording
Periprocedural of RF-TC
Questionnaire of Device Performance Evaluation
Time Frame: immediately after the procedure/surgery

a 5-level scale used to evaluate the Device Performance
immediately after the procedure/surgery
Seizure reduction rate
Time Frame: 90±7 days after RF-TC

Follow up
90±7 days after RF-TC
Mini-Mental State Examination (MMSE) score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events and serious adverse events
Time Frame: through study completion, an average of 5 months

Medical recording
through study completion, an average of 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Collaborators

Beijing Neo Science Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 23, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

October 21, 2026

First Submitted That Met QC Criteria

November 3, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLXX(X)&PINS-C2-01-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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