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

Recruiting

• Conditions: Major Depressive Disorder; Bipolar Disorder; Mild Cognitive Impairment

• Registration Number: NCT06897670
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Study Start: 2025-03-26
• Study First Posted: 2025-03-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2028-03-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States