Bipolar Disorder, Major Depressive Disorder, Mild Cognitive Impairment
Conditions
Keywords
functional near-infrared spectroscopy, diagnostics, mood disorders, mild cognitive impairment
Brief summary
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.
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.
Interventions
OTHERObservational 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.
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in oxyhemoglobin | Baseline, 60 minutes | Changes in oxyhemoglobin will be measured with a functional near-infrared spectroscopy (fNIRS) device by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Oxyhemoglobin results are reported as a percentage of oxygen-bound hemoglobin compared to the total hemoglobin in the blood. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D) | Baseline | A clinician-administered tool revaluating depression severity. The 17-item version assesses symptoms such as depressed mood, insomnia, and somatic complaints. Each item is scored on a 3- or 5-point scale, resulting in total scores that range from 0 to 52, with scores of 0-7 considered normal, 8-16 indicating mild depression, 17-23 moderate depression, and 24 or greater severe depression. |
| Young Mania Rating Scale (YMRS) | Baseline | A clinician-rated scale administered to measure the severity of manic symptoms in participants diagnosed with bipolar disorder (during manic or hypomanic episodes). It includes 11 items assessing areas such as elevated mood, irritability, and hyperactivity. Each item is scored on a scale of 0 to 4 or 0 to 8, with total scores ranging from 0 to 60. Severity thresholds include no significant symptoms (≤12), mild mania (13-20), moderate mania (21-35), and severe mania (\>35). |
| Clinical Global Impression-Bipolar (CGI-BP) | Baseline | A clinician-rated measure that provides a global assessment of illness severity, improvement, and therapeutic response in individuals with bipolar disorder. It includes separate ratings for mania, depression, and overall illness on a 7-point scale, where 1 indicates "normal, not at all ill" and 7 indicates "among the most severely ill." |
| Mini-Mental State Examination (MMSE) | Baseline | The Mini-Mental State Examination is used to assess domains such as orientation, attention, memory, language, and visuospatial skills. It has a maximum score of 30, with lower scores indicating greater cognitive impairment. Scores are typically categorized as no cognitive impairment (24-30), mild cognitive impairment (18-23), and severe cognitive impairment (0-17). |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline | The PHQ-9 is a self-report questionnaire used to measure the severity of depressive symptoms over the past two weeks. This questionnaire is used in our clinical practice and will be collected from patient only if not already completed. It consists of nine items, each scored on a scale from 0 ("Not at all") to 3 ("Nearly every day"), with total scores ranging from 0 to 27. Higher scores indicate greater symptom severity, categorized as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe depression (20-27). |
| Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Battery | Baseline | The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) is a standardized cognitive assessment tool designed to evaluate cognitive decline, particularly in Alzheimer's disease (AD) and mild cognitive impairment (MCI). It includes measures of verbal fluency, word list learning, delayed recall, recognition memory, constructional praxis, and global cognition. The battery incorporates a 15-item abbreviation of the Boston Naming Task (J2) and a slightly modified version of the MMSE that does not use serial 7s (J3). |
Countries
United States
Contacts
CONTACTSarah M. Williams
PRINCIPAL_INVESTIGATORMaria I. Lapid, M.D.
Mayo Clinic
PRINCIPAL_INVESTIGATORPaul H. Min, Ph.D.
Mayo Clinic
Outcome results
None listed