Event-Related Potential (ERP) Components in Clinical Diagnosis
NCT ID: NCT05673759
Last Updated: 2024-12-27
Study Results
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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SUSPENDED
200 participants
OBSERVATIONAL
2023-03-06
2025-12-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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75 Mild AD
75 patients diagnosed with Mild Alzheimer's disease.
Electroencephalogram (EEG) system
An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
Standard Neuropsychological Testing
Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
75 MCI due to any etiology
75 patients diagnosed with Mild Cognitive Impairment due to any etiology.
Electroencephalogram (EEG) system
An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
Standard Neuropsychological Testing
Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
25 Healthy Older Adults
25 Healthy older adults age: 50-90 (control).
Electroencephalogram (EEG) system
An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
Standard Neuropsychological Testing
Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
25 Healthy Younger Adults
25 Healthy younger adults age: 20-50 (control).
Electroencephalogram (EEG) system
An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
Standard Neuropsychological Testing
Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
Additional neuropsychological tests
Younger participants will receive additional testing along with the standard neuropsychological battery including Pittsburgh Sleep Quality Index (PSQI) \[37\] for sleep quality measures, the Test of Memory Malingering (TOMM) for effort measure, Ohio State Traumatic Brain Injury Identification Method questionnaire (OSU-TBI) \[38\] to gather lifetime TBI history, and the Neurobehavioral Symptom Inventory (NBSI) \[39\] for post-concussive symptoms. These additional tests will add an extra fifteen minutes, making the total time for neuropsychological questionnaires 1 hour in younger participants.
Interventions
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Electroencephalogram (EEG) system
An FDA 510(k) approved EEG/ERP device designed by G-Tec ™ intended for the acquisition, display, analysis, storage, reporting and management of EEG and auditory evoked potentials (AEP) information and uses Bluetooth technology to securely transmit EEG signals to a computer. The device is patient-friendly, and no serious adverse events have occurred to-date in any research or clinical study or in clinical use.
Standard Neuropsychological Testing
Prior to the EEG session, neuropsychological testing will be done to establish a baseline measurement. We administer a full standard neuropsychological battery (45 mins) for all participants which includes the following tests: MOCA (only for older participants), MMSE, CERAD, Phonemic Test and the Category Fluency test, Trails Making Test A and B, BNT, BAI, BDI, PANAS, Ishihara Color Blindness test, and the Snellen Eye Chart.
Additional neuropsychological tests
Younger participants will receive additional testing along with the standard neuropsychological battery including Pittsburgh Sleep Quality Index (PSQI) \[37\] for sleep quality measures, the Test of Memory Malingering (TOMM) for effort measure, Ohio State Traumatic Brain Injury Identification Method questionnaire (OSU-TBI) \[38\] to gather lifetime TBI history, and the Neurobehavioral Symptom Inventory (NBSI) \[39\] for post-concussive symptoms. These additional tests will add an extra fifteen minutes, making the total time for neuropsychological questionnaires 1 hour in younger participants.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
* 50-90 years old
* Mini-Mental State Examination (MMSE) 20-27
* Performance on delayed recall and recognition memory worse than 1.5 standard deviation (SD) for age and education
* Performance on delayed recall and recognition memory worse than 1.5 SD for age \& education in at least one other cognitive domain (e.g., language, executive functioning) based on other tests in our neuropsychological test battery.
* Dr. Turk and Dr. Budson will confirm all mild AD dementia diagnoses
For Mild cognitive impairment (MCI)
* MCI due to any etiology 50-90 years old
* MMSE \> 23
* Performance on delayed recall and recognition memory worse than 1.0 SD for age \& education adjusted norms
* Dr. Turk and Dr. Budson will confirm all MCI diagnoses
For Healthy older adults
* 50-90 years old
* Functioning normally in occupation determined by self-report
For Healthy younger adults
* 20-50 years old
* Functioning normally in occupation determined by self-report
Exclusion Criteria
* depression
* heavy alcohol or drug use
* cerebrovascular disease
* a different degenerative disease (e.g., fronto-temporal dementia, Parkinson's disease)
* any medical condition whose severity could significantly impair cognition (e.g., organ failure)
* on any antipsychotic or epilepsy medication
* Unable to understand the consent form
20 Years
90 Years
ALL
Yes
Sponsors
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VoxNeuro Inc.
UNKNOWN
Boston University
OTHER
Responsible Party
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Principal Investigators
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Katherine Turk, MD
Role: PRINCIPAL_INVESTIGATOR
BU Chobanian & Avedisian School of Medicine
Andrew Budson, MD
Role: PRINCIPAL_INVESTIGATOR
BU Chobanian & Avedisian School of Medicine
Locations
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BU Alzheimer Disease Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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H-43360
Identifier Type: -
Identifier Source: org_study_id