Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study

Launched by MAYO CLINIC · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to better understand how brain activity is affected in people with mood disorders, like major depressive disorder and bipolar disorder, as well as those with mild cognitive impairment (MCI). Researchers will use a safe and noninvasive technique called functional near-infrared spectroscopy (fNIRS) to measure brain activity. By comparing the brain patterns of different groups, they hope to learn more about how these conditions impact the brain and relate this information to the severity of symptoms.

To participate in this study, individuals must be 18 years or older and have a confirmed diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment. They should also be in a stable mental state without any acute episodes needing immediate care. Participants can expect to undergo simple tests and assessments related to their cognitive and emotional health. It's important to note that individuals with severe medical or neurological conditions, or those who have had certain psychiatric disorders, may not be eligible for this study. The trial is currently recruiting participants, and everyone is welcome to apply regardless of gender.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• General Inclusion Criteria (across all diagnostic groups):
• • 18 years and older
• • Ability to provide written informed consent
• • Adequate cognitive and language abilities to understand and complete study tasks, including clinical assessments and fNIRS procedures
• • Confirmed clinical diagnosis of major depressive disorder, bipolar disorder, or mild cognitive impairment (MCI)
• • Stable psychiatric or cognitive condition, without acute episodes requiring immediate intervention
• Specific Inclusion Criteria (for diagnostic groups):
• • Healthy control
• • o No past or current psychiatric or cognitive disorder
• * Major depressive disorder (MDD):
• • Diagnosis of major depressive disorder, confirmed through clinical evaluation.
• • No history of bipolar disorder or psychotic symptoms.
• * Bipolar disorder:
• • o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.
• * Mild Cognitive Impairment (MCI):
• • Pre-existing clinical diagnosis of mild cognitive impairment, supported by neuropsychological testing and/or MRI, PET scan data.
• • No history of major psychiatric disorders, such as major depression, bipolar disorder or schizophrenia.
• • Exclusion Criteria
• General Exclusion Criteria (across all diagnostic groups):
• • Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
• • Any severe or unstable medical condition that could interfere with participation or data collection
• • Any active neurological condition (including seizure disorder, traumatic brain injury, stroke) that could affect cognitive functioning or brain imaging results
• • Inability to comply with study procedures, including cognitive testing, fNIRS assessment, or other assessments required by the protocol
• • Pregnant women will be excluded due to potential physiological changes that could affect study outcomes
• Specific Exclusion Criteria (for diagnostic groups):
• • Healthy control
• • o Any past or current psychiatric or cognitive disorder
• * Major depressive disorder (MDD):
• • Diagnosis of bipolar disorder or schizophrenia.
• • Brain stimulation therapy within the past 3 months.
• * Bipolar disorder:
• • o Diagnosis of schizophrenia or schizoaffective disorder.
• * Mild Cognitive Impairment (MCI):
• • Diagnosis of dementia.
• • Significant cognitive impairment preventing understanding or completion of study tasks.

Trial Officials