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NCT Number: NCT07656857

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

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

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Intraoperative Monitoring Nervous System Diseases

Age range

3 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Du Cai Dr

CONTACT

[email protected]

86 01059975051

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Using High-density Flexible microElectrocorticography for intraoperative monitoring

Device

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Zhang Dr

CONTACT

[email protected]

86 01059975051

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Epi-PRECISE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 18, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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