Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
NCT ID: NCT06897670
Last Updated: 2025-04-13
Study Results
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Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2025-03-26
2028-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Healthy Controls
o No past or current psychiatric or cognitive disorder.
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: 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.
Major Depressive Disorder
* Diagnosis of major depressive disorder, confirmed through clinical evaluation.
* No history of bipolar disorder or psychotic symptoms.
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: 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
o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.
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: 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.
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.
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: 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.
Interventions
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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: 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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Maria I. Lapid, M.D.
Principal Investigator
Principal Investigators
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Maria I. Lapid, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Paul H. Min, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Sarah M. Williams
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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24-012395
Identifier Type: -
Identifier Source: org_study_id
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