High-density Flexible μECoG for Epilepsy Surgery - A Single-Arm ECT (Epi-PRECISE)
12 de agosto de 2026 atualizado 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?
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
- 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 estudo
Intervencional
Inscrição (Estimado)
85
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Kai Zhang Dr
- Número de telefone: 86 01059975051
- E-mail: zhangkai62035@sina.com
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100070
- Recrutamento
- Beijing Tiantan Hospital
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Contato:
- Du Cai Dr
- Número de telefone: 86 01059975051
- E-mail: ferryc22@163.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Seizure Freedom Rate at 6 Months After Surgery
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Seizure Freedom Rate at 1 Year After Surgery
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
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Publicações Gerais
- 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
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
31 de julho de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
15 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de junho de 2026
Primeira postagem (Real)
18 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de agosto de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KY2026-169-02
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