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

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

Overview

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

Detailed description

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.

Interventions

• Device Using High-density Flexible microElectrocorticography for intraoperative monitoring
  During resective epilepsy surgery, a sterile high-density flexible microelectrocorticography will be placed on the exposed cortical surface over the suspected epileptogenic zone and adjacent cortex. The array will be used for high-spatial-resolution intraoperative μECoG recording and real-time analysis of epileptiform activity, including interictal spikes, high-frequency oscillations, spatial discharge gradients, and propagation patterns. The intraoperative ECoG findings will be provided to the

Primary outcome measures

• Seizure Freedom Rate at 6 Months After Surgery [Time frame: From surgery to 6 months postoperatively]

Secondary outcome measures (11)

• Seizure Freedom Rate at 1 Year After Surgery [Time frame: From surgery to 1 year postoperatively]
• Postoperative Seizure Outcome According to ILAE Classification [Time frame: 6 months and 1 year postoperatively]
• Monthly Seizure Frequency [Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively]
• Seizure Severity Assessed by the National Hospital Seizure Severity Scale [Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively]
• Developmental Function Assessed by the Griffiths Mental Development Scales [Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively]
• Cognitive Function Assessed by the Wechsler Intelligence Scale for Children [Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively]
• Cognitive Function Assessed by the Mini-Mental State Examination [Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively]
• Quality of Life Assessed by the Quality of Life in Epilepsy Inventory-31 or the Pediatric Quality of Life Inventory Version 4.0 [Time frame: Baseline, 6 months postoperatively, and 1 year postoperatively]
• Postoperative Complications [Time frame: Perioperative period, 6 months postoperatively, and 1 year postoperatively]
• Surgery-Related Adverse Events [Time frame: Perioperative period]
• Serious Adverse Events [Time frame: Perioperative period]

Eligibility criteria

Inclusion criteria

• Age 3 to 60 years.
• Diagnosis of drug-resistant epilepsy, defined as persistent seizures despite treatment with two or more appropriately selected, adequately dosed and adequately tried antiseizure medications.
• Diagnosis of focal epilepsy after standard presurgical evaluation and considered suitable for resective epilepsy surgery.
• 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.
• Written informed consent provided by the participant or, when applicable, by a legal guardian.

Exclusion criteria

• Suspected mesial temporal lobe epilepsy after multidisciplinary presurgical evaluation.
• History of any previous neurosurgical craniotomy before epilepsy surgery.
• Severe psychiatric, cognitive, or psychological disorder that prevents participation in the study or completion of follow-up.
• Contraindication to surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Tiantan Hospital — Beijing

Publications

• Xingjian Liu, Chao Zhang, Baotian Zhao, et al., Preliminary application study of flexible high-density cortical electrodes in assisting localization of epileptogenic zones during epileptogenic zonectomy, Chinese Journal of Neurosurgery, 2025, 41(12):1237-1244. DOI:10.3760/cma.j.cn112050-20250919-00362
• Guo J, Wang Z, van 't Klooster MA, Van Der Salm SM, Leijten FS, Braun KP, Zijlmans M. Seizure Outcome After Intraoperative Electrocorticography-Tailored Epilepsy Surgery: A Systematic Review and Meta-Analysis. Neurology. 2024 Jun 11;102(11):e209430. doi: 10.1212/WNL.0000000000209430. Epub 2024 May 20. PMID 38768406

Identifiers

NCT: NCT07656857 · KY2026-169-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗