High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT (Epi-PRECISE)
12. August 2026 aktualisiert von: 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?
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
- 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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
85
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Kai Zhang Dr
- Telefonnummer: 86 01059975051
- E-Mail: zhangkai62035@sina.com
Studienorte
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100070
- Rekrutierung
- Beijing Tiantan Hospital
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Kontakt:
- Du Cai Dr
- Telefonnummer: 86 01059975051
- E-Mail: ferryc22@163.com
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-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Seizure Freedom Rate at 6 Months After Surgery
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Seizure Freedom Rate at 1 Year After Surgery
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
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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
Zeitfenster: 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.
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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
Zeitfenster: 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.
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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
Zeitfenster: 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
Zeitfenster: 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.
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Baseline, 6 months postoperatively, and 1 year postoperatively
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
31. Juli 2028
Studienabschluss (Geschätzt)
31. Dezember 2028
Studienanmeldedaten
Zuerst eingereicht
15. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Juni 2026
Zuerst gepostet (Tatsächlich)
18. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. August 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KY2026-169-02
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