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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

Potential participants will be identified from the Mayo Clinic outpatient clinics in the Departments of Psychiatry, Psychology, Neurology, and Primary Care.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels.

    Other intervention

    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.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Healthy Controls1 intervention
Group B: Major Depressive Disorder1 intervention
Group C: Bipolar Disorder1 intervention
Group D: Mild Cognitive Impairment (MCI)1 intervention

Trial outcomes

Primary outcomes

1

Changes in oxyhemoglobin

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.

Time frame
Baseline, 60 minutes

Secondary outcomes

1

Hamilton Depression Rating Scale (HAM-D)

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.

Time frame
Baseline
2

Young Mania Rating Scale (YMRS)

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).

Time frame
Baseline
3

Clinical Global Impression-Bipolar (CGI-BP)

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."

Time frame
Baseline
4

Mini-Mental State Examination (MMSE)

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).

Time frame
Baseline

Other outcomes

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