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

Overview

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

• 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.
  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:

Primary outcome measures

• Changes in oxyhemoglobin [Time frame: Baseline, 60 minutes]

Secondary outcome measures (6)

• Hamilton Depression Rating Scale (HAM-D) [Time frame: Baseline]
• Young Mania Rating Scale (YMRS) [Time frame: Baseline]
• Clinical Global Impression-Bipolar (CGI-BP) [Time frame: Baseline]
• Mini-Mental State Examination (MMSE) [Time frame: Baseline]
• Patient Health Questionnaire-9 (PHQ-9) [Time frame: Baseline]
• Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Battery [Time frame: Baseline]

Eligibility criteria

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 Exclusion Criteria (across all diagnostic groups):

• 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

Specific Exclusion Criteria (for diagnostic groups):

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Case-control

Study locations

United States · 1 center

• Mayo Clinic — Rochester

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06897670 · 24-012395

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗