High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT

Precision Resection of the Epileptogenic Zone Using Intraoperative Submillimeter Micro-Electrocorticography (Epi-PRECISE): A Single-Arm Trial With an External Historical Control Cohort

What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?

1. Compare the effect of intraoperative high-density flexible μECoG guidance versus no intraoperative μECoG guidance on surgical prognosis in patients with drug-resistant focal epilepsy.
2. Explore intraoperative electrophysiological biomarkers recorded by high-density μECoG that are associated with surgical prognosis.

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.