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Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

Primary Purpose

Epilepsy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard EEG
dry electrode EEG
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Epilepsy focused on measuring EEG, epilepsy, electroencephalography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • weave hairstyles

Sites / Locations

  • Miami VA Healthcare System, Miami, FL
  • Ralph H. Johnson VA Medical Center, Charleston, SC
  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

standard EEG

dry electrode EEG

Arm Description

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

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

Outcomes

Primary Outcome Measures

Detection of epileptiform activity in EEG.
Measuring the technical quality of the DES to record ETs versus the SES.

Secondary Outcome Measures

Procedure Costs of EEG.
Measuring procedure cost of DES versus SES.

Full Information

First Posted
March 16, 2022
Last Updated
October 11, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05380921
Brief Title
Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth
Official Title
Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
February 27, 2026 (Anticipated)
Study Completion Date
March 2, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Title: Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth Justification: Many Veterans live far away from a VAMC with substantial electroencephalography (EEG) expertise. Travel is difficult for epilepsy patients since they often cannot drive. The investigators propose to study a novel dry electrode system (DES) which does not require EEG technologists to operate and can be operated by a nurse assistant. This DES integrates the electrodes and EEG amplifier into a compact headset which is easily placed on the head (without skin preparation) and could be used in an epilepsy telemedicine outreach program along with clinical interviews. The investigators have performed three preliminary studies with DES headsets. In the first two studies in 33 Veterans performed at a VAMC, the investigators found that the DES was quick to apply, taking only 5-6 minutes to put on by a research subject with the assistance of a neurologist. Subjects preferred the DES headset over the standard EEG system (SES). In the third study a nurse performed 30 DES recordings in a VA community based outpatient clinic (CBOC). Rating of the EEG recordings on a five point scale by three board certified clinical EEG experts (after automated EEG artifact reduction was applied to the recordings) showed that all 30 recordings were of acceptable quality (rated 3 out of 5 or higher with some artifact present) and 18 of 30 recordings were of good quality (rate 4 or above with only minor artifacts present). Gaps to be address: 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 EEG. Being able to perform routine EEG in CBOCs can decrease cost to the VA system since DES EEG systems are less expensive and because Veterans will not have to travel to VAMCs for EEG. This study will also test the DES system to make sure it can record epileptiform transients (ETs), the pattern in EEG which indicates that patients have epilepsy. Innovativeness: This study is innovative because it will use a new recording system for EEG that just got FDA approval. This new DES EEG recording system provides a method for recording EEG which is cheaper and much easier to perform than conventional EEG. This study is also innovative because it will test for the first time if a DES can reliably record ETs. (The FDA approval for the DES system was based on EEG signal quality only and not whether it could reliably detect ETs.) The study will also use a new FDA-approved method for automatically removing artifactual signals which can obscure DES EEG recordings. Specific Aims: The first aim of the project is to test the ability of the DES to record ETs versus the SES. The second aim is to collect data on appointment wait time, appointment cancellation rate, and procedure cost of DES versus SES to project the improvement in Veteran access and potential cost-benefit of DES EEG performed in CBOCs versus SES EEG performed in VAMCs. Project Methods: This is a diagnostic device trial which will be performed at three sites: the Charleston VAMC, Durham VAMC, and Miami VAMC. For Specific Aim 1, 400 Veterans (200 with a history of an abnormal EEGs in which ETs were recorded and 200 prospective Veterans scheduled for an outpatient EEG) will be recruited to have a DES EEG procedure and a SES EEG procedure performed during a single study visit in a VAMC by an EEG technologist. Each EEG recording will be interpreted and rated for technical quality by three study investigators, who will also annotate the location of ETs in each EEG recording. The fraction of EEGs which demonstrate ETs and the technical quality ratings will be compared. For Specific Aim 2, data will be collected on 300 prospective Veterans scheduled for an outpatient routine EEG, including appointment cancellation rate, travel cost, and other patient factors. Costs for EEG equipment/supplies as well as technician effort/salary and nurse and nurse assistant effort/salary will also be collected. This will be used to project the potential improvement in patient access and potential cost savings of a nurse or nurse technician performing outpatient DES EEG in a CBOC versus an EEG technician performing outpatient SES EEG in a VAMC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
EEG, epilepsy, electroencephalography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
study investigators will score EEG quality in a blinded fashion.
Allocation
Non-Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard EEG
Arm Type
Experimental
Arm Description
all subjects will receive both a standard EEG and a dry electrode EEG
Arm Title
dry electrode EEG
Arm Type
Experimental
Arm Description
all subjects will receive both a standard EEG and a dry electrode EEG
Intervention Type
Device
Intervention Name(s)
standard EEG
Intervention Description
all subjects will receive both a standard EEG and a dry electrode EEG
Intervention Type
Device
Intervention Name(s)
dry electrode EEG
Intervention Description
all subjects will receive both a standard EEG and a dry electrode EEG
Primary Outcome Measure Information:
Title
Detection of epileptiform activity in EEG.
Description
Measuring the technical quality of the DES to record ETs versus the SES.
Time Frame
Through study completion, approximately 4 years.
Secondary Outcome Measure Information:
Title
Procedure Costs of EEG.
Description
Measuring procedure cost of DES versus SES.
Time Frame
Through study completion, approximately 4 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aim 1: subjects with history of an EEG within last five years at VA Aim 2: subjects scheduled for an outpatient EEG Exclusion Criteria: weave hairstyles
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan J Halford, MD
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249-0001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Testing a Novel Dry Electrode Headset for Electroencephalography Telehealth

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