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

June 15, 2026 updated by: Kai Zhang, Beijing Tiantan Hospital

Precision Resection of the Epileptogenic Zone Using Intraoperative Subdural High-density Flexible Electrocorticography - A Single-Arm Trial With an External Historical Control Cohort

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Compare the effect of intraoperative high-density flexible ECoG guidance versus no intraoperative ECoG guidance on surgical prognosis in patients with drug-resistant focal epilepsy.
  2. Explore intraoperative electrophysiological biomarkers recorded by high-density ECoG 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
        • 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. Aged 3 to 60 years.
  2. Diagnosed with drug-resistant epilepsy, defined as persistent seizures despite treatment with two or more appropriately selected, adequately dosed, and adequately tried antiseizure medications.
  3. Diagnosed with focal epilepsy after a standard presurgical epilepsy evaluation and considered suitable for resective epilepsy surgery.
  4. Preoperative Mini-Mental State Examination (MMSE) score ≥ 24.
  5. Able to provide written informed consent, or written informed consent provided by a legal guardian when applicable.

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 ECoG-Guided Resection
Device: High-density Flexible Electrocorticography
During resective epilepsy surgery, a sterile high-density flexible electrocorticography 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 ECoG 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 ECoG 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
Seizure Severity Assessed by NHS3
Time Frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Seizure severity will be assessed using the National Hospital Seizure Severity Scale before surgery and at 6 months and 1 year after surgery.
Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive Function Assessed by MMSE
Time Frame: Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive function will be evaluated using the Mini-Mental State Examination before surgery and at 6 months and 1 year after surgery.
Baseline, 6 months postoperatively, and 1 year postoperatively
Quality of Life Assessed by QOLIE-31 or PedsQL
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, and pediatric participants will be assessed using the Pediatric Quality of Life Inventory 4.0.
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

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)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 15, 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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