Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-25

Study Completion Date

2024-06-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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MCI Patients

Adult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site.

fNIRS measurement

Intervention Type OTHER

Kernel Flow2 measurements.

Healthy Controls

Healthy participants without a prior MCI or memory impairment diagnosis.

fNIRS measurement

Intervention Type OTHER

Kernel Flow2 measurements.

Interventions

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fNIRS measurement

Kernel Flow2 measurements.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients

* 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)

Exclusion Criteria

Patients

* 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
* Stroke
* Encephalitis
* Meningitis
* Epilepsy
* 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
* Stroke
* Encephalitis
* Meningitis
* Epilepsy
* TBI with serious results (coma, unconscious for \>2 hrs, or skull fracture)
* Current serious psychiatric conditions (bipolar disorder, schizophrenia, or psychosis)

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes