- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: ZheXiang Kuang, MSN
- Telefonnummer: 13920361752
- E-post: kuangzhexiang@ihcams.ac.cn
Studer Kontakt Backup
- Navn: Xiao Yu, Undergraduate
- Telefonnummer: 18722218448
- E-post: yuxiao@ihcams.ac.cn
Studiesteder
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina
- Rekruttering
- Regenerative Medicine Center
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Ta kontakt med:
- Xiao Yu, Undergraduate
- Telefonnummer: 18722218448
- E-post: yuxiao@ihcams.ac.cn
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- QTJC2026037
Plan for individuelle deltakerdata (IPD)
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Legemiddel- og utstyrsinformasjon, studiedokumenter
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