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fNIRS as a biomarker for individuals with subjective cognitive decline and MCI

fNIRS as a biomarker for individuals with subjective cognitive decline and MCI

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124936
Enrollment
Unknown
Registered
2026-05-19
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Interventions

Healthy control group:No
Subjective Cognitive Decline group:No

Sponsors

The First Affiliated Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The researchers first conducted a preliminary assessment of the participants according to the Jak/Bondi criteria to determine whether they met the diagnostic criteria for mild cognitive impairment (MCI). This assessment included tests across three cognitive domains: memory, language, and attention/executive function. Participants who scored abnormally low on these tests were classified as having MCI. The diagnostic criteria were explicitly defined as follows: scores on at least two neuropsychological measures within the same cognitive domain falling more than one standard deviation below the age- and education-adjusted normative mean, or abnormal performance observed across all three cognitive domains. Participants diagnosed with MCI were further subdivided into subgroups: those with impaired memory function were classified as amnestic MCI (aMCI), while those with impaired language ability, impaired attention/executive function (or a combination of both but without memory impairment) were classified as non-amnesic MCI (naMCI). The remaining participants who did not meet the MCI criteria were further classified as healthy controls (HC). These participants were assessed for everyday memory problems using the Subjective Cognitive Decline-Questionnaire 9 (SCD-Q9), which includes items such as "forgetting where objects are placed" or "forgetting important dates." One point was assigned for each memory-related complaint endorsed, resulting in a total SCD-Q9 score ranging from 0 to 9. Participants with a score below 5 were classified as HC, while those with a score of 5 or higher were classified as having subjective cognitive decline (SCD).

Exclusion criteria

Exclusion criteria: 1. Met the diagnostic criteria for dementia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 2. Had a history of severe diseases known to affect central nervous system function, such as Parkinson's disease, epilepsy, stroke (with confirmed neurological deficits), brain tumors, or a history of moderate to severe traumatic brain injury. 3. Had a history of severe psychiatric disorders, such as major depression (Hamilton Depression Rating Scale score >24), schizophrenia, or bipolar disorder. 4. Presented with severe aphasia, apraxia, agnosia, or visual field defects that precluded understanding instructions or cooperating with the eye-tracking test. 5. Had severe failure of major visceral organs (e.g., heart, liver, kidneys). 6. Had a history of current or previous alcohol or substance abuse. 7. Were currently taking or had a history of taking medications that may significantly affect central nervous system function (e.g., benzodiazepines, antipsychotics, cholinesterase inhibitors). 8. Had scalp lesions, infections, or intracranial metal implants that contraindicated the use of the functional near-infrared spectroscopy (fNIRS) probe cap.

Design outcomes

Primary

MeasureTime frame
Hemodynamic Levels of HbO in Bilateral Prefrontal Cortex Regions of Interest;

Secondary

MeasureTime frame
AST error rate;Error correction rate;Cortical thickness;AST latency;Completion time of TMT-A/B test;

Countries

China

Contacts

Public ContactNi Guoxin

The First Affiliated Hospital of Xiamen University

nigx@xmu.edu.cn+86 592 213 7084

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026