- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: ZheXiang Kuang, MSN
- Telefoonnummer: 13920361752
- E-mail: kuangzhexiang@ihcams.ac.cn
Studie Contact Back-up
- Naam: Xiao Yu, Undergraduate
- Telefoonnummer: 18722218448
- E-mail: yuxiao@ihcams.ac.cn
Studie Locaties
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, China
- Werving
- Regenerative Medicine Center
-
Contact:
- Xiao Yu, Undergraduate
- Telefoonnummer: 18722218448
- E-mail: yuxiao@ihcams.ac.cn
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)
Tijdsspanne: 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
Tijdsspanne: 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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Anxiety symptoms
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
|
Medewerkers en onderzoekers
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- QTJC2026037
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .