Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
IMPACT
IMPACT: Investigating Mild Cognitive Impairment in Patients And Controls With TD-fNIRS
1 other identifier
observational
133
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2023
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 25, 2023
CompletedFirst Submitted
Initial submission to the registry
August 2, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2024
CompletedJuly 3, 2024
July 1, 2024
11 months
August 2, 2023
July 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Brain hemodynamic activity with TD-fNIRS
This includes changes in the concentration of oxygenated and deoxygenated hemoglobin as measured by the change in light absorption.
About 1 hour during the study visit
Optical properties of the brain with TD-fNIRS
This measures how much light is absorbed at different points on the head.
About 1 hour during the study visit
Physiological features with TD-fNIRS
This includes cardiac measures, such as heart rate (HR) and heart rate variability (HRV).
About 1 hour during the study visit
Secondary Outcomes (6)
Mini-Mental State Evaluation (MMSE)
Within 6 months of the study visit
Mini-Cog
About 30 minutes during the study visit
Geriatric Depression Scale (Short Form)
About 30 minutes during the study visit
General Anxiety Disorder
About 30 minutes during the study visit
Apathy Evaluation Scale
About 30 minutes during the study visit
- +1 more secondary outcomes
Study Arms (2)
MCI Patients
Adult participants who are seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site.
Healthy Controls
Healthy participants without a prior MCI or memory impairment diagnosis.
Interventions
Eligibility Criteria
Adult participants seeking neurological assessments for Mild Cognitive Impairment (MCI) at a participating clinic/study site. A separate cohort of age-matched healthy participants will be recruited as the control group. The current study, including the acquired data and participation in the study, has no influence on diagnosis or treatment decisions.
You may qualify if:
- 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)
You may not qualify if:
- Patients
- Alzheimer's or dementia diagnosis
- 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)
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kernellead
Study Sites (6)
The Research Center of Southern California
Carlsbad, California, 92011, United States
BrainHealth Solutions
Costa Mesa, California, 92626, United States
The Research Center of Southern California
Escondido, California, 92029, United States
Kernel
Los Angeles, California, 90232, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
The Research Center of Southern California
Temecula, California, 92592, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine Perdue, PhD
Kernel
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2023
First Posted
August 18, 2023
Study Start
July 25, 2023
Primary Completion
June 13, 2024
Study Completion
June 13, 2024
Last Updated
July 3, 2024
Record last verified: 2024-07