Status:
RECRUITING
Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
Lead Sponsor:
Mayo Clinic
Conditions:
Major Depressive Disorder
Bipolar Disorder
Eligibility:
All Genders
18+ years
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 spectrosco...
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 func...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06897670
Start Date
March 26 2025
End Date
March 30 2028
Last Update
April 13 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905