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

NCT06897670 | Recruiting

• 1 other identifier: 24-012395
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Bipolar Disorder; Mild Cognitive Impairment

Keywords

functional near-infrared spectroscopy; diagnostics; mood disorders; mild cognitive impairment

Outcome Measures

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.

  Baseline, 60 minutes

Secondary Outcomes (6)

• Hamilton Depression Rating Scale (HAM-D)

  Baseline

• Young Mania Rating Scale (YMRS)

  Baseline

• Clinical Global Impression-Bipolar (CGI-BP)

  Baseline

• Mini-Mental State Examination (MMSE)

  Baseline

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline

Study Arms (4)

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.

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.

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.

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.

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

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; Healthy Controls; Major Depressive Disorder; Mild Cognitive Impairment (MCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Publications (7)

• Yucel MA, Selb JJ, Huppert TJ, Franceschini MA, Boas DA. Functional Near Infrared Spectroscopy: Enabling Routine Functional Brain Imaging. Curr Opin Biomed Eng. 2017 Dec;4:78-86. doi: 10.1016/j.cobme.2017.09.011. Epub 2017 Oct 6.

  PMID: 29457144 BACKGROUND

• Piper SK, Krueger A, Koch SP, Mehnert J, Habermehl C, Steinbrink J, Obrig H, Schmitz CH. A wearable multi-channel fNIRS system for brain imaging in freely moving subjects. Neuroimage. 2014 Jan 15;85 Pt 1(0 1):64-71. doi: 10.1016/j.neuroimage.2013.06.062. Epub 2013 Jun 28.

  PMID: 23810973 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

  PMID: 14399272 BACKGROUND

• Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429.

  PMID: 728692 BACKGROUND

• Spearing MK, Post RM, Leverich GS, Brandt D, Nolen W. Modification of the Clinical Global Impressions (CGI) Scale for use in bipolar illness (BP): the CGI-BP. Psychiatry Res. 1997 Dec 5;73(3):159-71. doi: 10.1016/s0165-1781(97)00123-6.

  PMID: 9481807 BACKGROUND

• Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.

  PMID: 2771064 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Cognitive Dysfunction; Mood Disorders

Interventions

Cerebrovascular Circulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mental Disorders; Bipolar and Related Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Blood Circulation; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Maria I. Lapid, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Paul H. Min, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah M. Williams

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)