High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT (Epi-PRECISE)
12 de agosto de 2026 actualizado por: 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?
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
- 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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
85
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Kai Zhang Dr
- Número de teléfono: 86 01059975051
- Correo electrónico: zhangkai62035@sina.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100070
- Reclutamiento
- Beijing Tiantan Hospital
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Contacto:
- Du Cai Dr
- Número de teléfono: 86 01059975051
- Correo electrónico: ferryc22@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intraoperative application of high-density flexible μECoG-Guided Resection
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Seizure Freedom Rate at 6 Months After Surgery
Periodo de tiempo: From surgery to 6 months postoperatively
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The proportion of participants who remain free from any type of epileptic seizure during the 6-month postoperative follow-up period.
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From surgery to 6 months postoperatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Seizure Freedom Rate at 1 Year After Surgery
Periodo de tiempo: From surgery to 1 year postoperatively
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The proportion of participants who remain free from any type of epileptic seizure during the 1-year postoperative follow-up period.
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From surgery to 1 year postoperatively
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Postoperative Seizure Outcome According to ILAE Classification
Periodo de tiempo: 6 months and 1 year postoperatively
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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.
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6 months and 1 year postoperatively
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Monthly Seizure Frequency
Periodo de tiempo: Baseline, 6 months postoperatively, and 1 year postoperatively
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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.
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Baseline, 6 months postoperatively, and 1 year postoperatively
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Postoperative Complications
Periodo de tiempo: Perioperative period, 6 months postoperatively, and 1 year postoperatively
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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.
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Perioperative period, 6 months postoperatively, and 1 year postoperatively
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Surgery-Related Adverse Events
Periodo de tiempo: Perioperative period
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The incidence of surgery-related adverse events will be recorded during the perioperative period.
Adverse events include events directly related to the surgical procedure.
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Perioperative period
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Serious Adverse Events
Periodo de tiempo: Perioperative period
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The incidence of serious adverse events, including postoperative death or severe deterioration of health status during the perioperative period, will be recorded.
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Perioperative period
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Seizure Severity Assessed by the National Hospital Seizure Severity Scale
Periodo de tiempo: Baseline, 6 months postoperatively, and 1 year postoperatively
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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.
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Baseline, 6 months postoperatively, and 1 year postoperatively
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Developmental Function Assessed by the Griffiths Mental Development Scales
Periodo de tiempo: Baseline, 6 months postoperatively, and 1 year postoperatively
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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.
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Baseline, 6 months postoperatively, and 1 year postoperatively
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Cognitive Function Assessed by the Wechsler Intelligence Scale for Children
Periodo de tiempo: Baseline, 6 months postoperatively, and 1 year postoperatively
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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.
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Baseline, 6 months postoperatively, and 1 year postoperatively
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Cognitive Function Assessed by the Mini-Mental State Examination
Periodo de tiempo: Baseline, 6 months postoperatively, and 1 year postoperatively
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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.
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Baseline, 6 months postoperatively, and 1 year postoperatively
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Quality of Life Assessed by the Quality of Life in Epilepsy Inventory-31 or the Pediatric Quality of Life Inventory Version 4.0
Periodo de tiempo: Baseline, 6 months postoperatively, and 1 year postoperatively
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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.
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Baseline, 6 months postoperatively, and 1 year postoperatively
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
31 de julio de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de junio de 2026
Publicado por primera vez (Actual)
18 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY2026-169-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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