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

12 août 2026 mis à jour par: 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?

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

  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.

Type d'étude

Interventionnel

Inscription (Estimé)

85

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100070
        • Recrutement
        • Beijing Tiantan Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intraoperative application of high-density flexible μECoG-Guided Resection
Dispositif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Seizure Freedom Rate at 6 Months After Surgery
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Seizure Freedom Rate at 1 Year After Surgery
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beijing Tiantan Hospital

Collaborateurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

31 juillet 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

15 juin 2026

Première soumission répondant aux critères de contrôle qualité

15 juin 2026

Première publication (Réel)

18 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 août 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • KY2026-169-02

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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