Continuous Electrographic Monitoring for Epilepsy

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wireless EEG patch designed to monitor brain activity in individuals with epilepsy or other seizure disorders. The researchers aim to determine if this patch performs as effectively as the traditional wired EEG used in hospitals. Participants will wear the patch to record brain activity during a scheduled overnight EEG test. This trial may suit those diagnosed with epilepsy or a seizure disorder who are scheduled for an overnight EEG test. Individuals allergic to adhesives should not participate. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future monitoring methods for seizure disorders.

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 prior data suggests that this wireless EEG patch is safe for human use?

Research has shown that the wireless EEG patch, which monitors brain activity, is safe for use. The FDA has approved the device, confirming it meets safety standards. Studies have found that this patch can successfully detect and predict seizures outside of hospitals. Importantly, these studies reported no major side effects, indicating that users generally tolerate the device well. Overall, the evidence supports the safety of the wireless EEG patch for ongoing brain activity monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wireless EEG patch for epilepsy because it offers a novel and convenient way to continuously monitor brain activity without the need for bulky equipment. Unlike traditional EEG systems that require patients to be tethered to a machine, this wireless patch provides the freedom to move around, making long-term monitoring more comfortable and practical. Additionally, the continuous data collection can potentially lead to better detection of seizures and more personalized treatment plans.

What evidence suggests that this wireless EEG patch is effective for epilepsy?

Previous studies have shown that a wireless EEG patch can effectively detect seizures by accurately recording brain activity. This patch alerts users to seizures using a single sensor to monitor the brain. Artificial intelligence supports the technology, enhancing seizure detection and tracking. Research indicates that the patch identifies seizures effectively in most cases. Overall, this approach could simplify and improve monitoring for people with epilepsy. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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

I have been diagnosed with epilepsy or another seizure disorder.

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

I am at least 5 years old.

Exclusion Criteria

Known or suspected allergy to adhesives

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11269262/

The present and future of seizure detection, prediction, and ... Seizure forecasting aims to identify when a person has a high or low likelihood of seizure, which is related to seizure prediction. Machine ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8315760/

Seizure Diaries and Forecasting With Wearables: Epilepsy ... Using smartphones to collect behavioral data in psychological science: opportunities, practical considerations, and challenges. Perspect Psychol Sci J Assoc ...

3. nature.com nature.com/articles/s41598-023-50609-z

EEG epilepsy seizure prediction: the post-processing stage ... The present work proposes a patient-specific seizure prediction algorithm using post-processing techniques to explore the existence of a set of chronological ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.704060/full

Forecasting Seizure Likelihood With Wearable Technology Wearable devices can be used to produce patient-specific seizure forecasts, particularly when biomarkers of seizure and epileptic activity cycles are utilized.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1059131124002887

The value of self-reported variables in epilepsy monitoring ... Among app and forecast users, 40 % found the forecast accurate for monitoring seizure risk, and 60 % used it for scheduling and mental well-being, while 40 % ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11555023/

Real‐world smartphone data can trace the behavioural impact ... Our findings suggest that the temporal dynamics of smartphone touchscreen interactions may help monitor neurobehavioural comorbidities in neurological care.

7. researchprotocols.org researchprotocols.org/2024/1/e60129

A Digital Intervention for Capturing the Real-Time Health ... One potential avenue for seizure forecasting is leveraging technologies that directly monitor brain activity, combining this with data analytics ...

8. medrxiv.org medrxiv.org/content/10.1101/2024.01.01.23300494v1.full-text

Real-world smartphone data can trace the behavioural ... We propose that the increased behavioural ageing in epilepsy is partly explained by ASM exposure and seizure occurrence. ASMs may cause a ...