Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not stated
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Heart tracing (ECG)
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Additionally, electrophysiological data, including photoplethysmography (PPG) and electrocardiogram (ECG), will be analyzed to investigate autonomic nervous system activity and its relationship with cerebral hemodynamics."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study uses fNIRS, a safe test that measures brain activity without surgery, to compare brain activity and symptom levels. It is for adults with depression, bipolar disorder, or mild memory and thinking problems, as well as adults without these conditions.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older.
- Can understand the study and give written consent to join.
- Can understand and complete study tasks and tests.
- Have a stable mental health or thinking condition, with no crisis needing immediate care.
- Healthy group: No past or current mental health or thinking disorder.
- Depression group: A confirmed diagnosis of major depression, with no history of bipolar disorder or symptoms of losing touch with reality.
- Bipolar group: A confirmed diagnosis of bipolar I or II disorder.
- Memory problems group: A prior diagnosis of mild cognitive impairment (mild memory and thinking problems), supported by thinking tests or brain scans. No history of major mental health disorders.
Who can't join
- An active disorder involving loss of touch with reality, or a substance use disorder, within the past year. Nicotine dependence is allowed.
- A severe or unstable medical condition that could affect taking part or collecting study results.
- An active brain or nerve condition, such as seizures, brain injury, or stroke, that could affect thinking or brain scans.
- Cannot complete study tasks or tests, or are pregnant.
- Healthy group: Any past or current mental health or thinking disorder.
- Depression group: Bipolar disorder, schizophrenia (a disorder that can affect contact with reality), or brain stimulation treatment in the past 3 months.
- Bipolar group: Schizophrenia or schizoaffective disorder (a condition involving mood problems and loss of touch with reality).
- Memory problems group: Dementia, or thinking problems severe enough to prevent understanding or completing study tasks.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
MN
- Mayo Clinic · Rochester, MN 55905Sarah M. Williams · Study contact · 507-422-2972Maria I. Lapid, M.D. · Principal investigatorPaul H. Min, Ph.D. · Principal investigatorMore trials in Rochester