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NCT Number: NCT07578675

Brain Cognitive Network Abnormalities in Anemia Patients Using 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.

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Key information

Conditions

Aplastic Anemia Anemia Anemia, Aplastic Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Autoimmune Hemolytic Anemia Bone Marrow Diseases Bone Marrow Failure Disorders Functional Near-infrared Spectroscopy Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Myelodysplastic Syndromes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Regenerative Medicine Center

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Xiao Yu, Undergraduate

CONTACT

[email protected]

18722218448

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Concentration changes in oxygenated hemoglobin (HbO) and de-oxygenated hemoglobin (HbR)

    Time frame: 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.

  2. Cognitive Function Assessment

    Time frame: 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.

Secondary outcomes

  1. Anxiety symptoms

    Time frame: 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.

  2. Depression symptoms

    Time frame: 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.

  3. Sleep quality

    Time frame: 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.

  4. Physical fatigue

    Time frame: 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.

  5. Appetite condition

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao Yu, Undergraduate

CONTACT

[email protected]

18722218448

ZheXiang Kuang, MSN

CONTACT

[email protected]

13920361752

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Collaborators

  • Tianjin University

Registry information

Official study title

Construction of Abnormal Projection Regions of Cognitive Neural Networks in Patients With Anemia Using Functional Near-Infrared Spectroscopy (fNIRS)

Acronym: AN-CNA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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