Dry Electrode EEG Headset for Epilepsy

Recruiting at 2 trial locations

Overseen By Kayla E Lamb, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Weave hairstyles

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

700 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Dry Electrode EEG for epilepsy?

Research shows that dry electrode EEG systems can provide quicker and potentially more convenient EEG recordings compared to traditional methods, which may help in better monitoring and managing epilepsy outside of hospital settings. ^{1 2 3 4 5}

Is the Dry Electrode EEG Headset safe for humans?

The research does not provide specific safety data for the Dry Electrode EEG Headset, but it mentions the use of EEG devices in various studies without reporting significant safety concerns. This suggests that EEG devices, in general, are considered safe for human use. ^{1 2 5 6 7}

How does the Dry Electrode EEG Headset treatment for epilepsy differ from other treatments?

The Dry Electrode EEG Headset is unique because it uses dry electrodes, which significantly reduce the time needed to set up the EEG compared to traditional wet electrodes. This makes it more convenient and accessible for patients, as it doesn't require the use of gels or extensive preparation, allowing for quicker and easier monitoring of brain activity. ^{3 4 8 9 10}

Research Team

Jonathan J Halford, MD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

This trial is for veterans with epilepsy who have had an EEG at a VA facility within the last five years and are scheduled for an outpatient EEG. It's not suitable for individuals with weave hairstyles, as this could interfere with the equipment.

Inclusion Criteria

Subjects with history of an EEG within last five years at VA

I am scheduled for an outpatient EEG test.

Exclusion Criteria

History of weave hairstyles

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Participants undergo both standard EEG and dry electrode EEG procedures to compare performance

Single visit

1 visit (in-person)

Data Collection and Analysis

Data on EEG quality, appointment wait time, cancellation rate, and procedure cost are collected and analyzed

Ongoing throughout study

Follow-up

Participants are monitored for any adverse effects and overall satisfaction with the EEG procedures

4 weeks

Treatment Details

Interventions

• Dry Electrode EEG
• Standard EEG

Trial Overview The study is testing a new dry electrode headset designed to record EEGs without needing a specialist technician. This device could enable nurses or assistants to perform EEGs in rural clinics, potentially improving access and reducing costs.

Participant Groups

Group I: standard EEG Experimental Treatment 1 Intervention

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

Group II: dry electrode EEG Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The Mayo Epilepsy Personal Assistant Device (EPAD) is designed to enhance seizure prediction and management by integrating with the Medtronic Summit RC+STM device for real-time monitoring of brain activity, which could improve the effectiveness of neuromodulation therapy.

The EPAD system is currently undergoing a first-in-human trial involving ten patients with difficult-to-treat epilepsy, following extensive testing on canines, indicating a strong commitment to safety and regulatory compliance in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. Pal Attia, T., Crepeau, D., Kremen, V., et al.[2022]

The study demonstrated that home monitoring of epilepsy patients using a subcutaneous EEG device is feasible and well tolerated, with no serious adverse events reported among the nine participants over a monitoring period of up to 3 months.

The device provided objective seizure counts that often differed significantly from patients' self-reported seizure diaries, revealing underreporting and important insights into seizure patterns and responses to antiepileptic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-long-term subcutaneous home monitoring of epilepsy-490 days of EEG from nine patients. Weisdorf, S., Duun-Henriksen, J., Kjeldsen, MJ., et al.[2021]

In a study of 1,019 epilepsy patients, those taking newer antiepileptic drugs (AEDs) reported adverse events (AEs) less frequently (61.3%) compared to those on older AEDs (71.1%), suggesting newer AEDs may be safer.

Patients on newer AEDs, particularly levetiracetam or lamotrigine, were less likely to change their treatment due to AEs, indicating these medications may provide a more stable treatment option for managing epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-interventional surveillance study of adverse events in patients with epilepsy. Cramer, JA., Steinborn, B., Striano, P., et al.[2015]

The ear-centered electroencephalography (ear-EEG) device was validated in a study with 10 healthy subjects over 12 nights, showing a strong agreement (average kappa value of 0.71) with traditional polysomnography (PSG) for sleep stage monitoring.

Participants found the ear-EEG system easy to use and more comfortable over time, suggesting that this generic device could provide a less obtrusive and effective alternative for long-term sleep monitoring compared to individualized systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

At-home sleep monitoring using generic ear-EEG. Tabar, YR., Mikkelsen, KB., Shenton, N., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ultra-long-term subcutaneous home monitoring of epilepsy-490 days of EEG from nine patients. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Quality assessment of electroencephalography obtained from a "dry electrode" system. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Comparison of a Novel Dry Electrode Headset to Standard Routine EEG in Veterans. [2017]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Electrographic seizure monitoring with a novel, wireless, single-channel EEG sensor. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Seizure-related adverse events during video-electroencephalography monitoring. [2012]

7. Denmark pubmed.ncbi.nlm.nih.gov

Non-interventional surveillance study of adverse events in patients with epilepsy. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Wireless User-Generic Ear EEG. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

A high-density 256-channel cap for dry electroencephalography. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

At-home sleep monitoring using generic ear-EEG. [2023]