Clinical trial NCT06897670: Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
Official title: Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder
Bipolar Disorder
Mild Cognitive Impairment
Keywords: functional near-infrared spectroscopy
diagnostics
mood disorders
mild cognitive impairment
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Primary outcomes:
measure: Changes in oxyhemoglobin
timeFrame: Baseline, 60 minutes
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: Baseline
measure: Young Mania Rating Scale (YMRS)
timeFrame: Baseline
measure: Clinical Global Impression-Bipolar (CGI-BP)
timeFrame: Baseline
measure: Mini-Mental State Examination (MMSE)
timeFrame: Baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Battery
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Maria I. Lapid, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Paul H. Min, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.