Dry Electrode EEG Headset for Epilepsy

Enrolling by invitation at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of EEG, which records brain activity, using a dry electrode headset that doesn't require a specialist to operate. The goal is to assist Veterans with epilepsy, particularly those in rural areas, by making EEGs more accessible and affordable. Participants will use both the new dry electrode EEG headset and the standard EEG to compare their effectiveness. This trial suits Veterans who have had an EEG in the last five years or are scheduled for one soon. As an unphased trial, it provides Veterans the opportunity to contribute to innovative research that could enhance EEG accessibility and affordability.

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 prior data suggests that this dry electrode EEG method is safe for recording EEGs?

Research has shown that dry electrode EEG systems are generally safe and easy to use. In one study with 59 patients, researchers collected over 2,721 hours of data and recorded 348 seizures without any major safety issues. Other studies have found these systems user-friendly, as they can be set up easily without needing a specialized EEG technician. This simplicity benefits people in rural areas.

Another study found that different dry-electrode devices work similarly well, indicating reliable performance across various models. While detailed safety data on side effects remains limited, the technology is considered noninvasive and has been successfully used to monitor seizures. This suggests that dry electrode EEG is a promising option for safe and accessible epilepsy monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the dry electrode EEG for epilepsy because it offers a non-invasive and quicker way to monitor brain activity compared to the traditional wet electrode EEG. Unlike the standard EEG, which requires a gel to conduct electrical signals, the dry electrode version eliminates the need for messy and time-consuming preparations. This makes it more comfortable for patients and potentially more accessible in various settings. Additionally, the ease of use could lead to more frequent and convenient monitoring, providing better insights into seizure patterns and ultimately improving patient care.

What evidence suggests that this dry electrode EEG headset is effective for epilepsy?

Research has shown that dry electrode EEG systems can perform as well as traditional EEGs in tracking brain activity. These systems record high-quality data without sticky gel or a complicated setup. In this trial, participants will receive both a standard EEG and a dry electrode EEG to compare their effectiveness. For people with epilepsy, devices like OptiEEG offer reliable monitoring and are easy to set up, making them suitable for home use. Studies confirm that dry electrode systems provide important medical information, similar to regular EEGs. Overall, this evidence supports using dry electrode EEGs as a practical and effective tool for diagnosing and monitoring epilepsy. ^{6 7 8 9 10}

Who Is on the Research Team?

Jonathan J Halford, MD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1388245719311988

Assessment of the technical usability and efficacy of a new ... This study evaluates the technical and practical usability and efficacy of the new portable dry-electrode EEG recorder in comparison to conventional EEG devices ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10098757/

Assessment of a 16-Channel Ambulatory Dry Electrode ... In this paper, we propose an ambulatory EEG device, OptiEEG, that has low setup complexity, for the remote EEG monitoring of epilepsy patients.

3. aesnet.org aesnet.org/abstractslisting/validation-of-a-dry-electrode-eeg-recording-system--results-of-a-multireader-blinded-comparison-to-standard-eeg-

Validation-of-a-dry-electrode-EEG-recording-system Overall, dry electrode systems can provide clinically relevant routine EEG recordings. Funding: Zeto Inc. provided funds to complete this study.

4. mdpi.com mdpi.com/1424-8220/25/16/5215

Recent Advances in Portable Dry Electrode EEG Dry electrodes have emerged as a promising alternative for EEG acquisition due to their ability to operate without conductive gel or complex skin preparation.

5. neurology.org neurology.org/doi/10.1212/WNL.92.15_supplement.P4.5-009

Validation of a dry-electrode EEG recording system Objective: To validate the effectiveness of Zeto EEG (zEEG) as a routine EEG by comparing the subjective quality of recordings with the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10597694/

PreEpiSeizures: description and outcomes of physiological ... The results achieved so far include 59 patients from 2 hospitals totaling 2,721 h of wearable data and 348 seizures.

7. nature.com nature.com/articles/s41598-025-18184-7

Benchmarking the utility of dry-electrode ... Our data suggest that the choice of a particular dry-electrode device may not critically influence the recording outcomes of auditory evoked ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016502701200177X

Quality assessment of electroencephalography obtained ... This study examines the difference in application times for routine electroencephalography (EEG) utilizing traditional electrodes and a “dry electrode” ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9311406/

Noninvasive mobile EEG as a tool for seizure monitoring ... Absence detection algorithm reached a sensitivity of 0.98 and false positives per hour rate of 0.91. Blind reading of full Sensor Dot data resulted in ...

10. mdpi.com mdpi.com/1424-8220/23/7/3654

Assessment of a 16-Channel Ambulatory Dry Electrode ... In this paper, we propose an ambulatory EEG device, OptiEEG, that has low setup complexity, for the remote EEG monitoring of epilepsy patients.