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Study on the Incremental Predictive Value of Early Resting-State EEG Phenotypes for Functional Prognosis and Risk Stratification in Acute Ischemic Stroke

28 de julho de 2026 atualizado por: Xuanwu Hospital, Beijing

This is a single-center, prospective, observational cohort study that plans to consecutively enroll 400 patients with acute ischemic stroke from July 2026 to July 2029. The study will not interfere with acute-phase treatment decisions; information on reperfusion and non-reperfusion treatment will be recorded according to the actual clinical care pathway. After completion of necessary acute treatment, once vital signs are stable and clinical conditions permit, all participants will undergo one resting-state EEG recording as early as possible, within 7 days after symptom onset or the last-known-well time. For patients receiving reperfusion therapy, EEG will be acquired after completion of the reperfusion procedure, and intervals such as onset-to-reperfusion initiation and completion of reperfusion-to-EEG acquisition will be recorded. For patients not receiving reperfusion therapy, EEG will be acquired after the stroke diagnosis is established, routine treatment has been initiated, and the clinical condition is stable; onset-to-admission and onset-to-EEG acquisition intervals will be recorded. EEG features will be extracted and combined with clinical and imaging variables to construct prognostic models. The primary outcome is functional outcome at 3 months after onset, dichotomized as mRS 0-2 versus 3-6. The primary analysis will evaluate the incremental predictive value of EEG phenotypes for poor 3-month functional outcome beyond a conventional clinical-imaging model. Secondary analyses will include validation of 6-month outcomes, functional and cognitive scale outcomes, and differences in EEG phenotypes across treatment pathways.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Derrame

Tipo de estudo

Observacional

Inscrição (Estimado)

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: Jun wei Hao, MD
Número de telefone: 01083198277
E-mail: haojunwei@vip.163.com

Locais de estudo

China
- - Beijing, China
    - Xuanwu Hospital
    - Contato:
      
      Junwei Hao, MD
      
      Número de telefone: 01083198277
      
      E-mail: haojunwei@vip.163.com

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

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra de Probabilidade

População do estudo

The study population will consist of stroke patients treated at Xuanwu Hospital, Capital Medical University. Participants will be grouped according to their actual treatment pathway into a reperfusion therapy group and a non-reperfusion therapy group. The study team will record the type of reperfusion therapy, key treatment time points, and related information.

Descrição

Inclusion Criteria:

Age >=18 years, regardless of sex;
Meets diagnostic criteria for acute ischemic stroke, supported by cranial CT/MRI and/or vascular imaging;
Symptom onset time or last-known-well time is clear;
Clinical assessment indicates that resting-state EEG can be completed without delaying acute treatment;
Pre-stroke mRS <=2, or basic independence in daily living before stroke;
The patient, legal guardian, or impartial witness provides informed consent to participate in this study.
The primary analysis population will be restricted to patients with mild-to-moderate to moderately severe acute ischemic stroke; an NIHSS score of 4-18 is recommended.

Exclusion Criteria:

Primary diagnosis of hemorrhagic stroke, cerebral venous sinus thrombosis, brain tumor, encephalitis, severe traumatic brain injury, or other non-ischemic brain injury;
Pre-existing marked neurological disability, pre-stroke mRS >2, severe prior dementia, or severe psychiatric disorder that would make follow-up functional or cognitive outcomes difficult to interpret;
Persistent deep sedation, coma, mechanical ventilation, severe metabolic disturbance, severe infection, or other conditions at the time of EEG acquisition that the investigator judges would markedly affect resting-state EEG background activity;
Status epilepticus or recent frequent clinical seizures around the time of EEG acquisition that the investigator judges would substantially affect interpretation of resting-state EEG;
Any other condition that the investigator judges unsuitable for participation in this study.

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Dichotomized mRS of 0-2 vs. 3-6 Prazo: 90(±28)days	Dichotomized mRS of 0-2 vs. 3-6 at 90±7 days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)	90(±28)days

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Ordinal mRS score Prazo: 90 (±28) days	Ordinal mRS score at 90 (±28) days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)	90 (±28) days
Dichotomized mRS of 0-2 vs. 3-6 Prazo: 180(±28) days	Dichotomized mRS of 0-2 vs. 3-6 at 180(±28) days; modified Rankin scale (range, 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)	180(±28) days
Score on the BI at 90 (±28) days and 180(±28) days Prazo: 90 (±28) days and 180(±28) days	Barthel Index，BI: The total score is 100 points. The higher the score, the better the independence and the lower the dependence.If the total score is ≤ 40 points, it indicates severe dependence, and full - time care by others is required.If the total score is between 41 - 60 points, it indicates moderate dependence, and most of the care needs to be provided by others.If the total score is between 61 - 99 points, it indicates mild dependence, and only a small part of care needs to be provided by others.If the total score is 100 points, it indicates no dependence, and no care from others is required.	90 (±28) days and 180(±28) days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Xuanwu Hospital, Beijing

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)

15 de julho de 2026

Conclusão Primária (Estimado)

15 de dezembro de 2026

Conclusão do estudo (Estimado)

28 de julho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez