ClinicalTrials.gov record NCT07578675
Brain Cognitive Network Abnormalities in Anemia Patients Using fNIRS
Construction of Abnormal Projection Regions of Cognitive Neural Networks in Patients With Anemia Using Functional Near-Infrared Spectroscopy (fNIRS)
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study uses functional near-infrared spectroscopy (fNIRS) to look for abnormal brain network activity in people with anemia. Participants will have fNIRS and several cognitive and symptom questionnaires shortly after hospital admission. The study seeks to map which brain regions show altered oxygenation and connectivity in anemia. Results aim to inform future clinical understanding and care strategies.
What it is studying. The study is testing which brain regions and network connections show abnormal oxygenated and de-oxygenated hemoglobin signals in people with anemia, and how those signals relate to cognitive scores and symptoms (anxiety, depression, sleep, fatigue, appetite). It will visualize connectivity changes (for example, heatmaps and arc-based maps) to identify affected neural network regions.
What the researchers hope to learn. To identify brain regions and network changes linked to anemia-related cognitive and symptom changes; to create visual maps of altered connectivity; and to produce data that may inform future clinical assessment and individualized care strategies.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
After giving written informed consent, participants will be assessed within 48 hours of admission. Assessments include a non-invasive brain scan using functional near-infrared spectroscopy (fNIRS) to measure oxygenated and deoxygenated hemoglobin, and standard questionnaires/tests of cognition and symptoms (Montreal Cognitive Assessment, HAMA, HAMD, PSQI, FACIT‑Fatigue, SNAQ). No invasive procedures are described in the registry. Participation involves these assessments while hospitalized.
How the study is structured. A prospective observational cohort. People with anemia who meet the study's enrollment criteria will be assessed within 48 hours of hospital admission. Assessments include non‑invasive fNIRS measurements of oxygenated and de-oxygenated hemoglobin, a cognitive test (MoCA), and questionnaires for anxiety, depression, sleep quality, fatigue, and appetite.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Oct 11, 2025
- Primary completion
- Mar 31, 2028 (estimated)
- Study completion
- Dec 31, 2028 (estimated)
- Target enrollment
- 323 participants (estimated)
- Last updated on registry
- Sep 18, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Collaborators
- Tianjin University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- ZheXiang Kuang, MSN 📞 13920361752 ✉ kuangzhexiang@ihcams.ac.cn
- Xiao Yu, Undergraduate 📞 18722218448 ✉ yuxiao@ihcams.ac.cn
Participating sites (1)
- Regenerative Medicine CenterRecruiting
Tianjin, Tianjin Municipality · China
- Xiao Yu, Undergraduate · 18722218448 · yuxiao@ihcams.ac.cn
Terms used on this page · explanations by MedicalUpdates.ai
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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