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

NCT07656857 | Recruiting DMC

• 1 other identifier: KY2026-169-02
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intraoperative Monitoring; Focal Epilepsy

Keywords

Epilepsy surgery; microelectrocorticography (μECoG)

Outcome Measures

Primary Outcomes (1)

• Seizure Freedom Rate at 6 Months After Surgery

  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 Outcomes (11)

• 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

• 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

Study Arms (1)

Intraoperative application of high-density flexible μECoG-Guided Resection

EXPERIMENTAL

Device: Using High-density Flexible microElectrocorticography for intraoperative monitoring

Interventions

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.

Intraoperative application of high-density flexible μECoG-Guided Resection

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (2)

• 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

  BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Monitoring, Intraoperative

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative

Central Study Contacts

Kai Zhang Dr

CONTACT

86 01059975051; zhangkai62035@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Neurosurgery, Clinical Professor

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-06

Locations

CN (1)