Continuous Electrographic Monitoring for Epilepsy

Recruiting at 2 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Epitel, Inc.

Disqualifiers: Allergy to adhesives

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

Compensation: Varies

Number of Visits: Unknown

750 Participants Needed

Trial Summary

What is the purpose of this trial?

This proposal will evaluate an individual-use, patch-type telemetry device for simplified, single-channel EEG recording from human patients along-side the traditional in hospital wired EEG.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

What data supports the effectiveness of the treatment Psychological and Behavioral interaction with a seizure forecasting mobile app, Seizure Alerting and Prediction System, Wireless EEG Patch for epilepsy?

Research shows that wireless EEG systems can effectively monitor seizures with good signal quality and low false alarm rates, making them useful for seizure detection and forecasting. Additionally, wearable devices for epilepsy management are generally well-received by patients, indicating they are comfortable and practical for long-term use. ^{1 2 3 4 5}

Is continuous electrographic monitoring for epilepsy safe for humans?

Research on wearable and implanted devices for epilepsy monitoring, like the Empatica E4 and Mayo Epilepsy Personal Assistant Device, shows they are generally safe for human use, with patients finding them acceptable and comfortable. However, ongoing development is needed to improve data quality and device management. ^{1 5 6 7 8}

How does the Wireless EEG Patch treatment for epilepsy differ from other treatments?

The Wireless EEG Patch is unique because it allows for continuous, real-time monitoring of brain activity through a small, wearable device, unlike traditional EEG systems that are bulky and often require patients to stay in a clinical setting. This wireless technology enables patients to go about their daily lives while still providing accurate seizure detection and localization. ^{1 2 3 4 9}

Eligibility Criteria

This trial is for individuals aged 5 and older with a previous epilepsy diagnosis, who are scheduled for at least an overnight EEG test. It's not suitable for those allergic to adhesives.

Inclusion Criteria

Admitted for scheduled EEG testing with a minimum of overnight (24 hour) EEG

I have been diagnosed with epilepsy or another seizure disorder.

I am at least 5 years old.

Exclusion Criteria

Known or suspected allergy to adhesives

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Inpatient Monitoring

Patients are monitored using both wired and wireless EEG devices in the epilepsy monitoring unit to develop a training dataset for machine learning algorithms.

1-7 days

Continuous monitoring in the hospital

Outpatient Monitoring

Patients use the wireless EEG device at home, providing data for seizure prediction and alerting through a mobile app.

90 days

Daily use at home

Follow-up

Participants are monitored for any device-related adverse events and overall study outcomes.

4 weeks

Treatment Details

Interventions

• Psychological and Behavioral interaction with a seizure forecasting mobile app
• Seizure Alerting and Prediction System
• Wireless EEG Patch

Trial Overview The study observes how patients interact with a seizure forecasting app while using a wireless, patch-type EEG device compared to traditional wired EEG monitoring in the hospital.

Participant Groups

Group I: Entire Study Experimental Treatment 3 Interventions

Each patient is eligible for all interventions in the study.

Who Is Running the Clinical Trial?

Epitel, Inc.

Lead Sponsor

Trials

4

Recruited

990+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Findings from Research

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]

Advanced EEG recording technologies, including subcutaneous and subgaleal electrodes, allow for long-term monitoring with good sensitivity and low false detection rates, making them suitable for automatic seizure detection and forecasting.

While these systems offer benefits like stable signals and minimal invasiveness, they also have limitations such as reduced spatial coverage and the need for surgical placement, highlighting the need for further validation in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review on the current long-term, limited lead electroencephalograms. Ulate-Campos, A., Loddenkemper, T.[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]

References

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

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

A novel telemetry system for recording EEG in small animals. [2011]

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

High density wireless EEG prototype: Design and evaluation against reference equipment. [2020]

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

Review on the current long-term, limited lead electroencephalograms. [2023]

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

Signal quality and patient experience with wearable devices for epilepsy management. [2021]

6. 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]

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

Video-EEG monitoring: safety and adverse events in 507 consecutive patients. [2014]

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

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

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

Wearable electroencephalography. What is it, why is it needed, and what does it entail? [2010]