Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

Part of paid clinical trials in Miami, Florida.

Sponsor
VA Office of Research and Development
Study ID
NCT05380921
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • standard EEG — DEVICE
    all subjects will receive both a standard EEG and a dry electrode EEG
  • dry electrode EEG — DEVICE
    all subjects will receive both a standard EEG and a dry electrode EEG

Study Details

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.

Key Dates

Start date
Oct 1, 2022
Status verified
Oct 2025
Primary completion
Sep 25, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
700 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: standard EEG
    all subjects will receive both a standard EEG and a dry electrode EEG
  • Experimental: dry electrode EEG
    all subjects will receive both a standard EEG and a dry electrode EEG

Primary Outcome Measure

Detection of epileptiform activity in EEG. [ Time Frame: Through study completion, approximately 4 years. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Miami VA Healthcare System, Miami, FLMiamiFlorida33125-
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703-
Richmond VA Medical Center, Richmond, VARichmondVirginia23249-0001-

Find similar trials in Miami, FL

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Miami VA Healthcare System, Miami, FL· Miami, FLRalph H. Johnson VA Medical Center, Charleston, SC· Charleston, SCRichmond VA Medical Center, Richmond, VA· Richmond, VA

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