Identifying Cerebral Hemodynamic Patterns in Mood Disorders and Mild Cognitive Impairment: A Functional Near-Infrared Spectroscopy (fNIRS) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in oxyhemoglobin
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bipolar Disorder
o Diagnosis of bipolar disorder I or II, confirmed through clinical evaluation.
干预措施: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels. (Other)
Healthy Controls
o No past or current psychiatric or cognitive disorder.
干预措施: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels. (Other)
Major Depressive Disorder
- Diagnosis of major depressive disorder, confirmed through clinical evaluation.
- No history of bipolar disorder or psychotic symptoms.
干预措施: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels. (Other)
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.
干预措施: Observational assessment using functional near-infrared spectroscopy (fNIRS), a noninvasive, portable brain imaging tool that measures changes in brain blood flow and oxygen levels. (Other)
结局指标
主要结局
Changes in oxyhemoglobin
时间窗: Baseline, 60 minutes
Changes in oxyhemoglobin will be measured with a functional near-infrared spectroscopy (fNIRS) device by radiating a near light beam, at two wavelengths of 780nm and 850nm of laser, into the cerebral cortex. Oxyhemoglobin results are reported as a percentage of oxygen-bound hemoglobin compared to the total hemoglobin in the blood.
次要结局
- Hamilton Depression Rating Scale (HAM-D)(Baseline)
- Young Mania Rating Scale (YMRS)(Baseline)
- Clinical Global Impression-Bipolar (CGI-BP)(Baseline)
- Mini-Mental State Examination (MMSE)(Baseline)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline)
- Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Battery(Baseline)
研究者
Maria I. Lapid, M.D.
Principal Investigator
Mayo Clinic