NCT06897670 · Mayo Clinic
Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations