- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ZheXiang Kuang, MSN
- Número de teléfono: 13920361752
- Correo electrónico: kuangzhexiang@ihcams.ac.cn
Copia de seguridad de contactos de estudio
- Nombre: Xiao Yu, Undergraduate
- Número de teléfono: 18722218448
- Correo electrónico: yuxiao@ihcams.ac.cn
Ubicaciones de estudio
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Porcelana
- Reclutamiento
- Regenerative Medicine Center
-
Contacto:
- Xiao Yu, Undergraduate
- Número de teléfono: 18722218448
- Correo electrónico: yuxiao@ihcams.ac.cn
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)
Periodo de tiempo: Patients will be assessed within 48 hours of admission.
|
Functional Near Infrared Spectroscopy (fNIRS) is a non-invasive brain imaging modality, that can be used to measure HbO and HbR concentrations.
|
Patients will be assessed within 48 hours of admission.
|
|
Cognitive Function Assessment
Periodo de tiempo: 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.
|
Patients will be assessed within 48 hours of admission.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anxiety symptoms
Periodo de tiempo: 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.
|
|
Depression symptoms
Periodo de tiempo: 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.
|
|
Sleep quality
Periodo de tiempo: 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.
|
Patients will be assessed within 48 hours of admission.
|
|
Physical fatigue
Periodo de tiempo: 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.
|
|
Appetite condition
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- QTJC2026037
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .