- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07578675
Brain Cognitive Network Abnormalities in Anemia Patients Using fNIRS (AN-CNA)
Construction of Abnormal Projection Regions of Cognitive Neural Networks in Patients With Anemia Using Functional Near-Infrared Spectroscopy (fNIRS)
Anemia is a global public health concern and is closely linked to dysfunction of brain cognitive neural networks, a key mechanism underlying cognitive impairment. Such deficits-including declines in memory, learning, processing speed, and executive function-reduce daily living abilities and increase risks of falls and depression.
Functional near-infrared spectroscopy (fNIRS) enables real-time monitoring of oxygenated and deoxygenated hemoglobin fluctuations, reflecting brain network function. This study aims to identify affected neural network regions in anemic patients and visualize connectivity changes using heatmaps and arc-based mapping. The findings will support early detection of cognitive impairment and guide precise clinical interventions, ultimately informing individualized treatment strategies to enhance therapeutic outcomes and quality of life.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: ZheXiang Kuang, MSN
- Número de telefone: 13920361752
- E-mail: kuangzhexiang@ihcams.ac.cn
Estude backup de contato
- Nome: Xiao Yu, Undergraduate
- Número de telefone: 18722218448
- E-mail: yuxiao@ihcams.ac.cn
Locais de estudo
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China
- Recrutamento
- Regenerative Medicine Center
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Contato:
- Xiao Yu, Undergraduate
- Número de telefone: 18722218448
- E-mail: yuxiao@ihcams.ac.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Diagnosis of anemia
- First hospitalization
- Male or female, aged 18-65 years
- Willing and able to comply with the requirements for this study and written informed consent
Exclusion Criteria:
- History of psychiatric illness
- History of severe brain disease
- Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study
Plano de estudo
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 |
|---|---|---|
|
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)
Prazo: Patients will be assessed within 48 hours of admission.
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Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations.
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Patients will be assessed within 48 hours of admission.
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Cognitive Function Assessment
Prazo: Patients will be assessed within 48 hours of admission.
|
Montreal Cognitive Assessment (MoCA) is used to assess cognitive function in patients, with higher total scores indicating better cognitive function.
The total score range is 0 to 30.
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Patients will be assessed within 48 hours of admission.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anxiety symptoms
Prazo: Patients will be assessed within 48 hours of admission.
|
Hamilton anxiety scale(HAMA) is used to examine anxiety in AIHA patients, with higher total scores indicate more severe anxiety symptoms.
The total score range is 0-56.
|
Patients will be assessed within 48 hours of admission.
|
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Depression symptoms
Prazo: Patients will be assessed within 48 hours of admission.
|
Hamilton depression scale(HAMD) is used to examine depression in AIHA patients, with higher total scores indicate more severe depression symptoms.
The total score range is 0-52.
|
Patients will be assessed within 48 hours of admission.
|
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Sleep quality
Prazo: Patients will be assessed within 48 hours of admission.
|
The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality, with a higher global score indicating poorer sleep quality.
The global score range is 0-21.
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Patients will be assessed within 48 hours of admission.
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Physical fatigue
Prazo: Patients will be assessed within 48 hours of admission.
|
It measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Scale.
The total possible score is 0-52 points, with higher scores indicating less fatigue.
|
Patients will be assessed within 48 hours of admission.
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Appetite condition
Prazo: Patients will be assessed within 48 hours of admission.
|
Simplified Nutritional Appetite Questionnaire (SNAQ) is used to assess appetite in patients, with higher total scores indicating better appetite.
The total score range is 4 to 20.
|
Patients will be assessed within 48 hours of admission.
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Colaboradores e Investigadores
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- QTJC2026037
Plano para dados de participantes individuais (IPD)
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