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

RECRUITING

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

NCT06897670•Mayo Clinic

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•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.
+5 more criteria

Exclusion Criteria

•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
•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.
+5 more criteria

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

March 26, 2025

Primary Completion Date

March 30, 2028

Completion Date

March 30, 2028

Last Updated

April 13, 2025

Enrollment

200

ESTIMATED participants

Conditions

Major Depressive DisorderBipolar DisorderMild Cognitive Impairment

Interventions

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

Contacts

Sarah M. Williams

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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