Event-Related Potential (ERP) Components in Clinical Diagnosis

NCT05673759 | Terminated FDA Device

• 1 other identifier: H-43360
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia, Mild; Mild Cognitive Impairment

Keywords

Memory Strategies; EEG headgear; Event-Related Potentials

Outcome Measures

Primary Outcomes (1)

• Electroencephalogram (EEG) memory diagnosis

  The EEG memory diagnosis will be arrived through the blinded review of the EEG data

  baseline

Secondary Outcomes (8)

• The Montreal Cognitive Assessment (MoCA) performance

  baseline

• Mini Mental State Examination (MMSE)

  baseline

• Consortium to Establish a Registry in Alzheimer's disease Word List Test (CERAD)

  baseline

• Verbal Fluency test: Phonemic Test and the Category Fluency test

  baseline

• Trails Making Test A and B

  baseline

Study Arms (4)

75 Mild AD

75 patients diagnosed with Mild Alzheimer's disease.

Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing

75 MCI due to any etiology

75 patients diagnosed with Mild Cognitive Impairment due to any etiology.

Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing

25 Healthy Older Adults

25 Healthy older adults age: 50-90 (control).

Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing

25 Healthy Younger Adults

25 Healthy younger adults age: 20-50 (control).

Device: Electroencephalogram (EEG) system; Behavioral: Standard Neuropsychological Testing; Behavioral: Additional neuropsychological tests

Interventions

Electroencephalogram (EEG) system DEVICE

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.

Also known as: g.Nautilus PRO (G-Tec ™)

25 Healthy Older Adults; 25 Healthy Younger Adults; 75 MCI due to any etiology; 75 Mild AD

Standard Neuropsychological Testing BEHAVIORAL

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.

Also known as: Neuropsychological Battery

25 Healthy Older Adults; 25 Healthy Younger Adults; 75 MCI due to any etiology; 75 Mild AD

Additional neuropsychological tests BEHAVIORAL

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.

25 Healthy Younger Adults

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any participant age: 20-90 years old, with or without a diagnosis of AD or cognitive impairment.

You may qualify if:

• For Mild Alzheimer Disease (AD) dementia
• Meets probable AD dementia National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
• 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
• years old
• Functioning normally in occupation determined by self-report

You may not qualify if:

• A clinically significant problem of any of the following conditions:
• 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

Sponsors & Collaborators

• Boston University: lead
• VoxNeuro Inc.: collaborator

Study Sites (1)

BU Alzheimer Disease Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Lymphoma, Follicular; Cognitive Dysfunction

Interventions

Electroencephalography; Drug Delivery Systems

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cognition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Drug Therapy; Therapeutics

Study Officials

• Katherine Turk, MD

  BU Chobanian & Avedisian School of Medicine

  PRINCIPAL INVESTIGATOR

• Andrew Budson, MD

  BU Chobanian & Avedisian School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 6, 2023
• Study Start: March 6, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)