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

15. juni 2026 opdateret af: Kai Zhang, Beijing Tiantan Hospital

Precision Resection of the Epileptogenic Zone Using Intraoperative Subdural High-density Flexible Electrocorticography - A Single-Arm Trial With an External Historical Control Cohort

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  1. Compare the effect of intraoperative high-density flexible ECoG guidance versus no intraoperative ECoG guidance on surgical prognosis in patients with drug-resistant focal epilepsy.
  2. Explore intraoperative electrophysiological biomarkers recorded by high-density ECoG that are associated with surgical prognosis.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

85

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100070
        • Beijing Tiantan Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Aged 3 to 60 years.
  2. Diagnosed with drug-resistant epilepsy, defined as persistent seizures despite treatment with two or more appropriately selected, adequately dosed, and adequately tried antiseizure medications.
  3. Diagnosed with focal epilepsy after a standard presurgical epilepsy evaluation and considered suitable for resective epilepsy surgery.
  4. Preoperative Mini-Mental State Examination (MMSE) score ≥ 24.
  5. Able to provide written informed consent, or written informed consent provided by a legal guardian when applicable.

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intraoperative application of high-density flexible ECoG-Guided Resection
Enhed: High-density Flexible Electrocorticography
During resective epilepsy surgery, a sterile high-density flexible electrocorticography 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 ECoG 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 ECoG is used for intraoperative recording only and will be removed before wound closure.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Seizure Freedom Rate at 6 Months After Surgery
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Seizure Freedom Rate at 1 Year After Surgery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Seizure Severity Assessed by NHS3
Tidsramme: Baseline, 6 months postoperatively, and 1 year postoperatively
Seizure severity will be assessed using the National Hospital Seizure Severity Scale before surgery and at 6 months and 1 year after surgery.
Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive Function Assessed by MMSE
Tidsramme: Baseline, 6 months postoperatively, and 1 year postoperatively
Cognitive function will be evaluated using the Mini-Mental State Examination before surgery and at 6 months and 1 year after surgery.
Baseline, 6 months postoperatively, and 1 year postoperatively
Quality of Life Assessed by QOLIE-31 or PedsQL
Tidsramme: 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, and pediatric participants will be assessed using the Pediatric Quality of Life Inventory 4.0.
Baseline, 6 months postoperatively, and 1 year postoperatively
Postoperative Complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Tiantan Hospital

Samarbejdspartnere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. juli 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

15. juni 2026

Først opslået (Faktiske)

18. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KY2026-169-02

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