High-density flexible microneuroelectrode mapping to guide epilepsy surgery
Official title: Precision Resection of the Epileptogenic Zone Using Intraoperative Submillimeter Micro-Electrocorticography (Epi-PRECISE): A Single-Arm Trial With an External Historical Control Cohort
Run by Beijing Tiantan Hospital · NCT07656857 · Data updated 2026-11-12
This study tests whether using high-density flexible microelectrocorticography during surgery helps guide the resection of the epileptogenic zone in people with drug-resistant focal epilepsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 60 Years |
| Sex | All |
| Enrollment | 85 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | July 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07656857 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children or adults with drug-resistant focal epilepsy being evaluated for resection who can tolerate intraoperative μECoG monitoring.
✕Probably not a fit
Patients whose seizures are not localized or who do not benefit from invasive monitoring may not experience improved outcomes.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this interventional, single-arm study, researchers will use high-density, flexible μECoG for intraoperative monitoring to guide surgical resection and compare outcomes to a baseline expectation without μECoG guidance. The study also seeks to identify electrophysiological biomarkers recorded by μECoG that correlate with better surgical prognosis. Participants undergo standard presurgical evaluation, receive μECoG-guided monitoring during resection, and are followed for postoperative outcomes. The goal is to determine whether μECoG guidance improves prognosis and to understand the biomarkers linked to successful outcomes.
Why it matters
Potential benefit: If successful, patients could have more precise seizures zone delineation and potentially better surgical outcomes.
How similar studies have gone: Similar intraoperative electrophysiological approaches have shown promise in guiding resections, but this exact high-density μECoG strategy is being explored for its potential added value.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 3 to 60 years. 2. Diagnosis of drug-resistant epilepsy, defined as persistent seizures despite treatment with two or more appropriately selected, adequately dosed and adequately tried antiseizure medications. 3. Diagnosis of focal epilepsy after standard presurgical evaluation and considered suitable for resective epilepsy surgery. 4. Preoperative cognitive or developmental status sufficient to participate in study assessments, as judged by the investigator and assessed using age-appropriate validated instruments. For participants aged 3 to 6 years, developmental status must be within the normal range according to the Griffiths Mental Development Scales. For participants aged 6 to 16 years, cognitive function must be within the normal range according to the Wechsler Intelligence Scale for Children. For participants older than 16 years, a Mini-Mental State Examination score of 24 or higher will be required. 5. Written informed consent provided by the participant or, when applicable, by a legal guardian. Exclusion Criteria: 1. Suspected mesial temporal lobe epilepsy after multidisciplinary presurgical evaluation. 2. History of any previous neurosurgical craniotomy before epilepsy surgery. 3. Severe psychiatric, cognitive, or psychological disorder that prevents participation in the study or completion of follow-up. 4. Contraindication to surgery.
Where it's running
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Kai Zhang Dr
- Email: zhangkai62035@sina.com
- Phone: 86 01059975051
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.