Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-31 @ 4:03 PM
Study NCT ID:
NCT05673759
Status:
TERMINATED
Last Update Posted:
2025-12-16
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Event-Related Potential (ERP) Components in Clinical Diagnosis
Sponsor:
Boston University
Organization:
Study Overview
Official Title:
The Clinical Utility of ERPs in the Diagnosis of Cognitive Impairment
Status:
TERMINATED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor stopped funding the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study, the investigators will use a novel electroencephalogram (EEG) system that participants will wear during a single in-person research session to investigate whether ERPs are now ready for validation as a tool clinicians can easily implement to increase diagnostic accuracy and confidence. This EEG will not be used to treat, cure, mitigate or diagnosis any disease and there will be no safety or efficacy data collected about the machine for any purpose including support of FDA submission.
The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management.
The investigators will compare the ERP data to that of neuropsychological testing in order to determine the degree of correlation between these two measures. Questionnaires on cognition, mood, and fluency will be administered prior to the EEG to establish a baseline. ERP data from the EEG session will be compared with the results of the neuropsychological battery in order to determine whether the implementation of ERPs in the existing workflow of clinicians can aid in diagnostic accuracy, thus altering clinical management.
Detailed Description:
A cross sectional cohort study design with four groups will be implemented to determine how ERPs can provide diagnostic information and alter clinical management beyond that of neuropsychological testing alone in patients with Alzheimer's disease (AD) or Mild Cognitive Impairment (MCI).
Secondary Objectives:
* To determine the impact of ERP testing (using cognitive health assessment reports) on change in research grade clinical diagnosis
* To determine the degree of correlation between quantitative ERP measures with neuropsychological testing performance using a standardized neuropsychological battery.
75 mild AD dementia and 75 MCI due to any etiology, 25 Older Adults (OA) and 25 Younger Adults (YA) will be enrolled over the course of two years. Each subject will participate in the study for 1 visit.
The in person 50-60-minute testing session consists of a neuropsychological battery, and an EEG session with computer tasks including the Auditory Oddball paradigm, a Continuous Visual Memory Test, Auditory Evoked Potentials, Visual Evoked Potentials, the Erikson Flanker Task, and the Hayling Task.
Secondary Objectives:
* To determine the impact of ERP testing (using cognitive health assessment reports) on change in research grade clinical diagnosis
* To determine the degree of correlation between quantitative ERP measures with neuropsychological testing performance using a standardized neuropsychological battery.
75 mild AD dementia and 75 MCI due to any etiology, 25 Older Adults (OA) and 25 Younger Adults (YA) will be enrolled over the course of two years. Each subject will participate in the study for 1 visit.
The in person 50-60-minute testing session consists of a neuropsychological battery, and an EEG session with computer tasks including the Auditory Oddball paradigm, a Continuous Visual Memory Test, Auditory Evoked Potentials, Visual Evoked Potentials, the Erikson Flanker Task, and the Hayling Task.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: