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

12 augustus 2026 bijgewerkt door: 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?

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

  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.

Studietype

Ingrijpend

Inschrijving (Geschat)

85

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Werving
        • Beijing Tiantan Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intraoperative application of high-density flexible μECoG-Guided Resection
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Seizure Freedom Rate at 6 Months After Surgery
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Seizure Freedom Rate at 1 Year After Surgery
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beijing Tiantan Hospital

Medewerkers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

31 juli 2028

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

15 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 juni 2026

Eerst geplaatst (Werkelijk)

18 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

12 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • KY2026-169-02

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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