IMPACT: Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 133
- 试验地点
- 4
- 主要终点
- Brain hemodynamic activity with TD-fNIRS
研究概览
简要总结
The goal of the proposed observational, multi-site study is to use fNIRS neurophysiological data recorded during a battery of tasks to detect MCI within a cohort consisting of patients and age-matched healthy controls. Furthermore, the investigators aim to explore whether they can measure the severity of MCI symptoms in the patient population. If successful, this approach enables clinicians to track the disease at its source-the brain; possibly allowing for earlier detection of MCI and its progression, and ultimately more efficient interventions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a diagnosis of MCI (amnesiac or non-amnesiac) as determined by clinician
- •Adults (older adults) between the ages of 55-85 years inclusive at time of enrollment
- •Ability to perform informed consent on their own
- •Fluent in English (speaking and reading)
- •Healthy Controls
- •Adults (older adults) between the ages of 55-85 years inclusive at time of enrollment
- •Ability to perform informed consent on their own
- •Fluent in English (speaking and reading)
排除标准
- •Alzheimer's or dementia diagnosis
- •Current substance or alcohol dependence, and/or alcohol or substance abuse as determined by CAGE-AID assessment for drug and alcohol abuse. A score of 2 or higher would result in exclusion.
- •Has uncorrected major visual or auditory deficits that would prevent them from completing a study task
- •Current or recent (in the past 6 months) chemotherapy and/or radiation for any cancer
- •Major medical illnesses and psychiatric conditions (other than MCI) including:
- •Severe/uncontrolled Diabetes, hypertension and hypothyroidism that could pose secondary causes of cognitive decline
- •Parkinson's disease
- •Motor neuron diseases
- •Multiple Sclerosis
- •Brain Tumor
- •Encephalitis
- •Meningitis
- •TBI with serious results (coma, unconscious for >2 hrs, or skull fracture)
- •Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis)
- •Healthy Controls
- •Prior MCI or memory impairment diagnosis
- •First-degree relative with dementia or clinically relevant memory problems
- •Alzheimer's or dementia diagnosis
- •Current substance or alcohol dependence, and/or alcohol or substance abuse as determined by CAGE-AID assessment for drug and alcohol abuse. A score of 2 or higher would result in exclusion.
- •Has uncorrected major visual or auditory deficits that would prevent them from completing a study task
- •Current or recent (in the past 6 months) chemotherapy and/or radiation for any cancer
- •Major medical illnesses and psychiatric conditions including:
- •Severe/uncontrolled Diabetes, hypertension and hypothyroidism that could pose secondary causes of cognitive decline
- •Parkinson's disease
- •Motor neuron diseases
- •Multiple Sclerosis
- •Brain Tumor
- •Encephalitis
- •Meningitis
- •TBI with serious results (coma, unconscious for >2 hrs, or skull fracture)
- •Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis)
结局指标
主要结局
Brain hemodynamic activity with TD-fNIRS
时间窗: About 1 hour during the study visit
This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.
Optical properties of the brain with TD-fNIRS
时间窗: About 1 hour during the study visit
This measures how much light is absorbed at different points on the head.
Physiological features with TD-fNIRS
时间窗: About 1 hour during the study visit
This includes cardiac measures, such as heart rate (HR) and heart rate variability (HRV).
次要结局
- Mini-Mental State Evaluation (MMSE)(Within 6 months of the study visit)
- Geriatric Depression Scale (Short Form)(About 30 minutes during the study visit)
- Mini-Cog(About 30 minutes during the study visit)
- Apathy Evaluation Scale(About 30 minutes during the study visit)
- General Anxiety Disorder(About 30 minutes during the study visit)
- Alzheimer's Disease Cooperative Study Activities of Daily Living for Mild Cognitive Impairment (ADCS ADL-MCI)(About 30 minutes during the study visit)