Purpose

The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). By comparing brain activity across different groups and relating it to symptom severity, this study aims to improve our understanding of how these conditions affect the brain.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Healthy Controls o No past or current psychiatric or cognitive disorder.
  • Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.
    Functional near-infrared spectroscopy (fNIRS) transcutaneously measures changes in oxyhemoglobin in the prefrontal cortex using light detection. It is designed to measure variations in cerebral hemodynamics on a real-time basis by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Participants will undergo a one-time functional near-infrared spectroscopy (fNIRS) procedure to measure cerebral hemodynamic patterns. - Resting-State Measurement: 5-10 min resting-state scans. - Task-Based Measurement: Participants will be shown an instruction video. Participants will complete a Verbal Fluency Task (VFT) during the fNIRS scan (15-20 min). - During the fNIRS scan, optional basic vital signs will be measured using respiratory belts, photoplethysmography (PPG), and electrocardiogram (ECG). - Each participant will complete 3 sets of resting-state and task-based measurements. Total estimated time for fNIRS assessment: 45-60 min.
Major Depressive Disorder - Diagnosis of major depressive disorder, confirmed through clinical evaluation. - No history of bipolar disorder or psychotic symptoms.
  • Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.
    Functional near-infrared spectroscopy (fNIRS) transcutaneously measures changes in oxyhemoglobin in the prefrontal cortex using light detection. It is designed to measure variations in cerebral hemodynamics on a real-time basis by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Participants will undergo a one-time functional near-infrared spectroscopy (fNIRS) procedure to measure cerebral hemodynamic patterns. - Resting-State Measurement: 5-10 min resting-state scans. - Task-Based Measurement: Participants will be shown an instruction video. Participants will complete a Verbal Fluency Task (VFT) during the fNIRS scan (15-20 min). - During the fNIRS scan, optional basic vital signs will be measured using respiratory belts, photoplethysmography (PPG), and electrocardiogram (ECG). - Each participant will complete 3 sets of resting-state and task-based measurements. Total estimated time for fNIRS assessment: 45-60 min.
Bipolar Disorder o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.
  • Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.
    Functional near-infrared spectroscopy (fNIRS) transcutaneously measures changes in oxyhemoglobin in the prefrontal cortex using light detection. It is designed to measure variations in cerebral hemodynamics on a real-time basis by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Participants will undergo a one-time functional near-infrared spectroscopy (fNIRS) procedure to measure cerebral hemodynamic patterns. - Resting-State Measurement: 5-10 min resting-state scans. - Task-Based Measurement: Participants will be shown an instruction video. Participants will complete a Verbal Fluency Task (VFT) during the fNIRS scan (15-20 min). - During the fNIRS scan, optional basic vital signs will be measured using respiratory belts, photoplethysmography (PPG), and electrocardiogram (ECG). - Each participant will complete 3 sets of resting-state and task-based measurements. Total estimated time for fNIRS assessment: 45-60 min.
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.
  • Other: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.
    Functional near-infrared spectroscopy (fNIRS) transcutaneously measures changes in oxyhemoglobin in the prefrontal cortex using light detection. It is designed to measure variations in cerebral hemodynamics on a real-time basis by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Participants will undergo a one-time functional near-infrared spectroscopy (fNIRS) procedure to measure cerebral hemodynamic patterns. - Resting-State Measurement: 5-10 min resting-state scans. - Task-Based Measurement: Participants will be shown an instruction video. Participants will complete a Verbal Fluency Task (VFT) during the fNIRS scan (15-20 min). - During the fNIRS scan, optional basic vital signs will be measured using respiratory belts, photoplethysmography (PPG), and electrocardiogram (ECG). - Each participant will complete 3 sets of resting-state and task-based measurements. Total estimated time for fNIRS assessment: 45-60 min.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Sarah M. Williams
507-422-2972
Williams.Sarah2@mayo.edu

Detailed Description

This study will examine cerebral hemodynamic patterns in individuals with mood disorders (major depressive disorder and bipolar disorder) and cognitive disorders (mild cognitive impairment) using functional near-infrared spectroscopy (fNIRS). The primary goal is to compare hemodynamic patterns between these groups, while the secondary goal is to explore correlations between these patterns and symptom severity based on standardized clinical assessments. Additionally, electrophysiological data, including photoplethysmography (PPG) and electrocardiogram (ECG), will be analyzed to investigate autonomic nervous system activity and its relationship with cerebral hemodynamics.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.