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Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

NCT05380921 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-10-14

No results posted yet for this study

Summary

This study will improve access of Veterans with epilepsy living in rural areas to the most important diagnostic procedure for the care of patients with epilepsy: the routine electroencephalogram (EEG). The investigators will test a new method for recording EEG which uses a novel dry electrode system headset that does not require an EEG technologist to operate. The headset integrates the EEG electrodes and amplifier into a compact system which is easily placed on the head. This approach could make it possible for a nurse or nurse assistant with minimal training to record an EEG in a rural community based outpatient clinic (CBOC) as part of an epilepsy telemedicine outreach program along with clinical interviews. The investigators will compare performance of this dry electrode system to standard EEG when it is used by EEG technologists in three VA medical centers. This project has the potential to improve access of Veterans to the EEG procedure and decrease cost to the Veterans Health Care System.

Conditions

Interventions

DEVICE

standard EEG

all subjects will receive both a standard EEG and a dry electrode EEG

DEVICE

dry electrode EEG

all subjects will receive both a standard EEG and a dry electrode EEG

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jonathan J Halford, MD · Ralph H. Johnson VA Medical Center, Charleston, SC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2026-09-25
Completion
2026-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05380921 on ClinicalTrials.gov