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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new portable EEG device, the Remote EEG Monitoring System, which records brain activity over an extended period to better understand seizures. The researchers aim to determine if recording for 14 to 28 days in a home setting captures more seizures than the usual 3-day monitoring. They also seek to assess whether doctors find this additional information helpful. Individuals who experience seizures at least every two weeks and are already undergoing EEG as part of their care might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance seizure monitoring for many patients.

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 prior data suggests that the Remote EEG Monitoring System is safe for long-term use?

Research has shown that the REMI Remote EEG Monitoring System is safe and effective in both healthcare facilities and at-home settings. This portable device monitors brain activity and is safe for long-term use in these environments. Data supports its effectiveness and safety.

Studies confirm that ultra-long-term EEG monitoring systems are safe and comfortable for users. These systems enable continuous brain monitoring over extended periods, aiding doctors in understanding seizure patterns. Research has demonstrated that these devices meet electrical safety standards, ensuring user safety.

Overall, both the REMI system and ultra-long-term EEG monitoring have been tested and proven safe for real-world use, providing valuable information without significant risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new methods for long-term EEG monitoring for epilepsy because they offer more flexibility and convenience than traditional in-hospital EEG monitoring. The Remote EEG Monitoring System allows patients to be monitored from the comfort of their own homes, reducing the need for lengthy hospital stays. Additionally, the Ultra-long-term Ambulatory EEG Monitoring provides continuous data collection over extended periods, which can lead to more accurate diagnoses and better understanding of seizure patterns. These advancements promise to enhance patient quality of life and improve epilepsy management by providing more comprehensive and accessible monitoring solutions.

What evidence suggests that this Remote EEG Monitoring System is effective for epilepsy?

Research has shown that the Remote EEG Monitoring System (REMI) effectively tracks seizure events over long periods. In one study, epilepsy specialists accurately reviewed EEG data from REMI sensors, proving its reliability. Another study confirmed that REMI safely and effectively monitors seizures from a distance.

Long-term portable EEG monitoring, like Ultra-long-term Ambulatory EEG Monitoring, also shows promise. It captures seizure events even in patients who rarely experience them, aiding doctors in diagnosing epilepsy more accurately. This extended monitoring in real-life settings provides valuable data for doctors. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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+

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]

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 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]

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]

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 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8558398/

Wearable Reduced-Channel EEG System for Remote ... This is the first study showing epileptologists' ability to blindly review EEG from four Epilog sensors in the REMI montage, and the results ...

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K243185.pdf

May 21, 2025 Epitel, Inc. Christopher Phillips VP, Regulatory ... Performance Data. The REMI Remote EEG Monitoring System was tested to verify its design and to validate its safe and effective use for the ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0920121124000494

A systematic review of the literature reporting on remote ... This review aims to examine the technical characteristics, device performance, user preference, and effectiveness of remote monitoring seizure detection devices ...

4. researchprotocols.org researchprotocols.org/2022/2/e33812/

Remote Electroencephalography Monitoring of Epilepsy in ... This scoping review will summarize the state of the field of remote EEG monitoring interventions for adults with epilepsy and provide an overview of the ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/epi.18365

Validation of a discrete electrographic seizure detection ... The performance of a novel automated seizure detection algorithm for reduced-channel EEG (Epitel) was evaluated in a clinical validation study involving 50 ...

6. epitel.com epitel.com/

Epitel The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings ...

7. epitel.com epitel.com/healthcare-facility-use

REMI™ Healthcare Facility The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8917432/

Remote Electroencephalography Monitoring of Epilepsy in ... This scoping review will summarize the state of the field of remote EEG monitoring interventions for adults with epilepsy and provide an overview of the ...

9. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.728484/full

Wearable Reduced-Channel EEG System for Remote ... Four Epilog sensors are combined as part of Epitel's Remote EEG Monitoring platform (REMI) to create 10 channels of EEG for remote patient ...