High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT (Epi-PRECISE)

July 6, 2026 updated by: Kai Zhang, Beijing Tiantan Hospital

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative application of high-density flexible μECoG-Guided Resection
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 surgical team to assist in defining the epileptogenic zone and tailoring the extent of resection. The high-density μECoG is used for intraoperative recording only and will be removed before wound closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From surgery to 6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure Freedom Rate at 1 Year After Surgery
Time Frame: From surgery to 1 year postoperatively
The proportion of participants who remain free from any type of epileptic seizure during the 1-year postoperative follow-up period.
From surgery to 1 year postoperatively
Postoperative Seizure Outcome According to ILAE Classification
Time Frame: 6 months and 1 year postoperatively
Postoperative seizure outcome will be evaluated using the International League Against Epilepsy classification at 6 months and 1 year after surgery. ILAE class 1 indicates complete seizure freedom without aura, and higher classes indicate worse seizure outcomes.
6 months and 1 year postoperatively
Monthly Seizure Frequency
Time Frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Monthly seizure frequency will be assessed before surgery and at 6 months and 1 year after surgery. The measure is defined as the average number of epileptic seizures per month.
Baseline, 6 months postoperatively, and 1 year postoperatively
Postoperative Complications
Time Frame: Perioperative period, 6 months postoperatively, and 1 year postoperatively
The incidence of postoperative complications, including infection, fever, neurological deficits, and other surgery-related complications, will be recorded during the perioperative period and postoperative follow-up.
Perioperative period, 6 months postoperatively, and 1 year postoperatively
Surgery-Related Adverse Events
Time Frame: Perioperative period
The incidence of surgery-related adverse events will be recorded during the perioperative period. Adverse events include events directly related to the surgical procedure.
Perioperative period
Serious Adverse Events
Time Frame: Perioperative period
The incidence of serious adverse events, including postoperative death or severe deterioration of health status during the perioperative period, will be recorded.
Perioperative period
Seizure Severity Assessed by the National Hospital Seizure Severity Scale
Time Frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Seizure severity will be assessed using the National Hospital Seizure Severity Scale (NHS3) before surgery and at 6 months and 1 year after surgery. The NHS3 is a seizure severity scale with scores ranging from 1 to 27, with higher scores indicating more severe seizures and therefore a worse outcome.
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
For participants aged 3 to 6 years, developmental function will be evaluated using the Griffiths Mental Development Scales before surgery and at 6 months and 1 year after surgery. The primary reported score will be the General Developmental Quotient or General Quotient. The quotient score ranges from 50 to 150, with higher scores indicating better developmental function and therefore a better outcome.
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
For participants aged 6 to 16 years, cognitive function will be evaluated using the Wechsler Intelligence Scale for Children before surgery and at 6 months and 1 year after surgery. The primary reported score will be the Full Scale Intelligence Quotient. The Full Scale Intelligence Quotient standard score ranges from 40 to 160, with higher scores indicating better cognitive function and therefore a better outcome.
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
For participants older than 16 years, cognitive function will be evaluated using the Mini-Mental State Examination (MMSE) before surgery and at 6 months and 1 year after surgery. The MMSE total score ranges from 0 to 30, with higher scores indicating better cognitive function and therefore a better outcome.
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
Quality of life will be evaluated before surgery and at 6 months and 1 year after surgery. Adult participants will be assessed using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31), and pediatric participants will be assessed using the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0). Both scales are transformed to scores ranging from 0 to 100, with higher scores indicating better quality of life and therefore a better outcome.
Baseline, 6 months postoperatively, and 1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Collaborators

Peking University First Hospital
Beijing Fengtai Hospital
Beijing Neurosurgical Institute
Beijing Xinzhida Neural Technology Co., Ltd
The Chinese University of Hong Kong, Shenzhen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 15, 2026

First Posted (Actual)

June 18, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2026-169-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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