NCT07656857RecruitingNot Applicable
Precision Resection of the Epileptogenic Zone Using Intraoperative Submillimeter Micro-Electrocorticography (Epi-PRECISE): A Single-Arm Trial With an External Historical Control Cohort
Beijing Tiantan Hospital1 site in 1 country85 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Seizure Freedom Rate at 6 Months After Surgery
Study Overview
Brief Summary
What's the clinical value of high-density flexible microelectrocorticography (μECoG) for guiding the resection of epileptogenic zone (EZ) in epilepsy surgery?
Detailed Description
- 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.
- Explore intraoperative electrophysiological biomarkers recorded by high-density μECoG that are associated with surgical prognosis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Outcome assessors will be blinded to group allocation when evaluating postoperative seizure outcomes. Due to the surgical nature of the intervention, participants, care providers, and investigators cannot be masked.
Eligibility Criteria
- Ages
- 3 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intraoperative application of high-density flexible μECoG-Guided Resection
Experimental
Intervention: Using High-density Flexible microElectrocorticography for intraoperative monitoring (Device)
Outcomes
Primary Outcomes
Seizure Freedom Rate at 6 Months After Surgery
Time Frame: From surgery to 6 months postoperatively
The proportion of participants who remain free from any type of epileptic seizure during the 6-month postoperative follow-up period.
Secondary Outcomes
- Seizure Severity Assessed by the National Hospital Seizure Severity Scale(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Developmental Function Assessed by the Griffiths Mental Development Scales(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Cognitive Function Assessed by the Wechsler Intelligence Scale for Children(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Cognitive Function Assessed by the Mini-Mental State Examination(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(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Seizure Freedom Rate at 1 Year After Surgery(From surgery to 1 year postoperatively)
- Postoperative Seizure Outcome According to ILAE Classification(6 months and 1 year postoperatively)
- Monthly Seizure Frequency(Baseline, 6 months postoperatively, and 1 year postoperatively)
- Postoperative Complications(Perioperative period, 6 months postoperatively, and 1 year postoperatively)
- Surgery-Related Adverse Events(Perioperative period)
- Serious Adverse Events(Perioperative period)
Investigators
Kai Zhang
Director of the Department of Neurosurgery, Clinical Professor
Beijing Neurosurgical Institute
Study Sites (1)
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