An interventional study of SEEG RF-TC in Drug-Resistant Epilepsy, sponsored by Beijing Pins Medical Co., Ltd. Not yet recruiting at 17 sites in China. Open to participants aged 2 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Beijing Pins Medical Co., Ltd · Not applicable, Interventional, and Treatment
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.
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.
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
This study's planned enrollment of 99 is above the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →Beijing Pins Medical Co., Ltd is the lead sponsor of 31 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: SEEG-guided radiofrequency thermocoagulation
SEEG Recording Success Rate
The proportion of patients achieving successful SEEG recording
Time frame: 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.
Time frame: Within 3 days after RF-TC
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.
Time frame: Within 30 days after implantation of electrodes
Technical success rate of RF-TC
Medical recording
Time frame: During RF-TC operation
Vital signs-body temperature
From medical recording
Time frame: baseline, Perioperative
Vital signs-pulse
From medical recording
Time frame: baseline, Perioperative
Vital signs-respiratory rate
From medical recording
Time frame: baseline, Perioperative
Vital signs-blood pressure
From medical recording
Time frame: baseline, Perioperative
the reduction rate of spike frequency after RF-TC
SEEG recording
Time frame: Periprocedural of RF-TC
Questionnaire of Device Performance Evaluation
a 5-level scale used to evaluate the Device Performance
Time frame: immediately after the procedure/surgery
Seizure reduction rate
Follow up
Time frame: 90±7 days after RF-TC
Mini-Mental State Examination (MMSE) score
Lower score indicates worse cognitive impairment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before and 90±7 days after RF-TC
Incidence of adverse events and serious adverse events
Medical recording
Time frame: through study completion, an average of 5 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
Of 102 interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 50. This study's planned 8 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beijing Pins Medical Co., Ltd →