Event-Related Potential (ERP) Components in Clinical Diagnosis

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.

Conditions

• Alzheimer Disease
• Dementia, Mild
• Mild Cognitive Impairment

Interventions

DEVICE

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• VoxNeuro Inc.

  collaborator UNKNOWN

• Boston University

  lead OTHER

Principal Investigators

• Katherine Turk, MD · BU Chobanian & Avedisian School of Medicine

• Andrew Budson, MD · BU Chobanian & Avedisian School of Medicine

Eligibility

Min Age

20 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-06

Primary Completion

2025-05-01

Completion

2025-05-01

FDA Device

Yes

Countries

• United States

Study Locations