Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

NCT05380921 | Enrolling By Invitation FDA Device

• 2 other identifiers: IIR 19-408HX003107
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 3

Brief 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

Epilepsy

Keywords

EEG; epilepsy; electroencephalography; Point-of-Care Systems

Outcome Measures

Primary Outcomes (1)

• Detection of epileptiform activity in EEG.

  Measuring the technical quality of the DES to record ETs versus the SES.

  Through study completion, approximately 4 years.

Secondary Outcomes (1)

• Procedure Costs of EEG.

  Through study completion, approximately 4 years.

Study Arms (2)

standard EEG

EXPERIMENTAL

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

Device: standard EEG

dry electrode EEG

EXPERIMENTAL

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

Device: dry electrode EEG

Interventions

standard EEG DEVICE

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

standard EEG

dry electrode EEG DEVICE

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

dry electrode EEG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1: subjects with history of an EEG within last five years at VA
• Aim 2: subjects scheduled for an outpatient EEG

You may not qualify if:

• weave hairstyles

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

Richmond VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

Location

Related Publications (1)

• Halford JJ, Campobello G, Brinkmann BH, Stead M, Rampp S, Remi J, Nilsen KB, Dauwels J, Galanti M, Dean BC, Winkler S, Ehrenberg JA, Pfaff J, Sullivan GJ. Letter to the Editor: Announcement of a Call for Proposals for biomedical waveform coding. Clin Neurophysiol. 2024 Sep;165:88-89. doi: 10.1016/j.clinph.2024.06.010. Epub 2024 Jul 2. No abstract available.

  PMID: 38991377 RESULT

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jonathan J Halford, MD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: study investigators will score EEG quality in a blinded fashion.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: study subjects will receive first a standard EEG study and then after this a dry electrode EEG study (in this sequence) at each study visit.

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: May 19, 2022
• Study Start: October 1, 2022
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)