Long-Term EEG Monitoring for Epilepsy

(REMI Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Epitel, Inc.

Disqualifiers: Allergies, Enrolled in other trials, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14-28 days

65 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test Epitel's™ Remote EEG Monitoring System's (REMI™) ability to record electroencephalography (EEG) of seizure events in an ambulatory setting for extended periods (14 - 28 days) in patients presenting with questionable seizure characterization. The main questions it aims to answer are: • Can more seizure events be recorded in fourteen (14) days than can be recorded in three (3) days? • Do treating clinicians find clinical value in extended fourteen (14) - twenty-eight (28) days of EEG? Participants will wear a portable EEG device (REMI) for fourteen (14) to twenty-eight (28) days in their home/community setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the focus is on monitoring seizures with a portable EEG device.

What data supports the effectiveness of the treatment Remote EEG Monitoring System, REMI, for epilepsy?

The REMI system, which uses Epilog sensors, was shown to have a high accuracy in detecting seizures remotely, with epileptologists achieving 90% sensitivity and specificity in identifying patients experiencing seizures. Additionally, the automated seizure detection algorithm demonstrated 100% sensitivity in identifying seizure activity, indicating REMI's potential as an effective tool for remote epilepsy monitoring. ^{1 2 3 4 5}

Is long-term EEG monitoring for epilepsy safe for humans?

The studies on remote EEG monitoring systems, like Epitel's REMI, show that they are generally safe for human use. These systems have been tested for accuracy and reliability in detecting seizures, and no significant safety concerns have been reported in the available research. ^{1 2 4 6 7}

How does the Remote EEG Monitoring System differ from other epilepsy treatments?

The Remote EEG Monitoring System (REMI) is unique because it allows for long-term, remote monitoring of brain activity using wearable sensors, which can be administered by non-specialized medical personnel. This system provides comprehensive spatial EEG recordings and includes an automated seizure detection algorithm, making it distinct from traditional in-clinic EEG monitoring. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for adults aged 18-70 with a history of seizures, who can consent to the study and follow procedures. They must be willing to wear an EEG device almost all day (20+ hours) for up to 30 days and have at least one seizure every two weeks. It's not suitable for those in other trials, allergic to certain medical materials, without stable housing or power supply.

Inclusion Criteria

Can understand and sign written informed consent, or have a legal guardian provide consent

I have a history of seizures.

I (or my caregiver) can follow all the study's instructions.

Exclusion Criteria

Cannot read, speak, or understand English (and does not have a translator)

You are allergic to certain materials used in medical devices like acrylics, silicones, or hydrogels.

You don't have a place to live or your home doesn't have electricity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear a portable EEG device (REMI) for monitoring seizure events in an ambulatory setting

14-28 days

Continuous monitoring in home/community setting

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Remote EEG Monitoring System
• Ultra-long-term Ambulatory EEG Monitoring

Trial Overview The REMI™ system by Epitel is being tested to see if it can capture more seizure events over a longer period (14-28 days) compared to traditional methods. The study will evaluate whether extended EEG monitoring provides valuable information for clinicians treating epilepsy.

Remote EEG Monitoring System is already approved in United States for the following indications:

Approved in United States as REMI for:

• Detection of electrographic seizures
• Ambulatory EEG monitoring

Who Is Running the Clinical Trial?

Epitel, Inc.

Lead Sponsor

Trials

4

Recruited

990+

Findings from Research

The OptiEEG device offers a low-complexity solution for remote monitoring of epilepsy patients, addressing the limitations of existing ambulatory EEG devices that are not suitable for remote use.

Comparative tests showed that while OptiEEG had slightly lower signal quality than the gold standard Natus device, its performance was still within acceptable limits, making it a viable option for long-term EEG monitoring outside clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of a 16-Channel Ambulatory Dry Electrode EEG for Remote Monitoring. Shivaraja, TR., Remli, R., Kamal, N., et al.[2023]

The Epilog EEG sensor system, used in the Remote EEG Monitoring platform (REMI), allows for accurate remote monitoring of patients, with epileptologists achieving 90% sensitivity and specificity in detecting electrographic seizure activity from the EEG data of 20 subjects over 5 days.

The automated seizure detection algorithm demonstrated excellent performance, achieving 100% sensitivity for detecting electrographic seizure activity and 90% sensitivity for individual focal onset seizures, indicating its potential as a reliable clinical decision support tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable Reduced-Channel EEG System for Remote Seizure Monitoring. Frankel, MA., Lehmkuhle, MJ., Spitz, MC., et al.[2022]

The introduction of eight-channel ambulatory EEG monitoring enhances the ability to localize attacks and EEG abnormalities compared to the traditional four-channel system, improving the overall assessment of seizure types.

Ambulatory EEG monitoring has proven effective in evaluating the efficacy of anticonvulsant medications and studying the impact of environmental factors and circadian rhythms on seizure activity, making it a valuable tool for both clinical and experimental research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty-four hour ambulatory EEG monitoring: development and applications. Powell, TE., Harding, GF.[2019]

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]

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 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]

The Nelli® hybrid video/audio monitoring system successfully identified clinically relevant events in 80% of the 104 patients studied, capturing 2767 epileptic seizures and aiding in clinical decision-making for therapeutic interventions in 68% of cases.

The system facilitated significant changes in treatment plans for 51.9% of patients, including adjustments to antiseizure medications and referrals for presurgical evaluations, demonstrating its effectiveness in optimizing seizure management in a home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of a video/audio-based epilepsy monitoring system Nelli. Basnyat, P., Mäkinen, J., Saarinen, JT., et al.[2022]

Wearable devices that monitor various physiological signals, such as accelerometry and electrodermal activity, show promise in detecting seizures and providing objective data, which could improve the reliability of seizure monitoring compared to traditional self-reported diaries.

While non-invasive and minimally invasive EEG methods have demonstrated the ability to accurately record seizure activity over long periods, challenges remain in user acceptability and the identification of different seizure types, highlighting the need for further research and development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizure Diaries and Forecasting With Wearables: Epilepsy Monitoring Outside the Clinic. Brinkmann, BH., Karoly, PJ., Nurse, ES., et al.[2021]

References

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

Assessment of a 16-Channel Ambulatory Dry Electrode EEG for Remote Monitoring. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Wearable Reduced-Channel EEG System for Remote Seizure Monitoring. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Twenty-four hour ambulatory EEG monitoring: development and applications. [2019]

4. 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]

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

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

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

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

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

Clinical utility of a video/audio-based epilepsy monitoring system Nelli. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Seizure Diaries and Forecasting With Wearables: Epilepsy Monitoring Outside the Clinic. [2021]