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.

Study Overview

• Status: Recruiting
• Conditions: Myelodysplastic Syndromes; Aplastic Anemia; Autoimmune Hemolytic Anemia; Functional Near-Infrared Spectroscopy

• Study Type: Observational
• Enrollment (Estimated): 323

Contacts and Locations

• Study Contact: Name: ZheXiang Kuang, MSN; Phone Number: 13920361752; Email: kuangzhexiang@ihcams.ac.cn
• Study Contact Backup: Name: Xiao Yu, Undergraduate; Phone Number: 18722218448; Email: yuxiao@ihcams.ac.cn

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • Recruiting
      • Regenerative Medicine Center
      • Contact: Xiao Yu, Undergraduate; Phone Number: 18722218448; Email: yuxiao@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with anemia who were hospitalized for the first time during the period from 2026 to 2028.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)	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	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety symptoms	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China
• Collaborators: Tianjin University

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Failure Disorders; Autoimmune Diseases; Immune System Diseases; Hematologic Diseases; Bone Marrow Diseases; Anemia, Hemolytic; Anemia; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Anemia, Aplastic; Anemia, Hemolytic, Autoimmune
• Other Study ID Numbers: QTJC2026037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No