UNEEG SubQ Device for Epilepsy

(FORESITE Trial)

Overseen By William Tauer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: AEDs

Must not be taking: Anticoagulants, Aspirin

Disqualifiers: Substance abuse, Psychiatric hospitalization, others

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

Compensation: Varies

Number of Visits: 7

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and practicality of using a small device implanted under the scalp to predict seizures in people with epilepsy. The UNEEG SubQ device records brain activity in the temporal lobe and aims to help manage seizures more effectively. It targets individuals with temporal lobe epilepsy who experience at least two disabling seizures per month and have maintained stable medication doses recently. Participants should be able to keep a seizure diary and attend regular study visits. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance seizure management for many.

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

The trial does not specify if you need to stop taking your current medications. However, your anti-epileptic drug (AED) dosages must have been stable for at least 3 months before joining the study.

What prior data suggests that the UNEEG SubQ device is safe for epilepsy patients?

Research has shown that subscalp EEG devices, such as the UNEEG SubQ, are generally well-tolerated. These devices enable long-term brain monitoring in everyday life, allowing extended use without major issues.

One study found that using a similar device for up to nine days in people was safe and practical. The procedure is simple, reducing the likelihood of harm or complications. Another study demonstrated that a related device could continuously manage epilepsy, reliably detecting seizures without major safety concerns.

Overall, the UNEEG SubQ device appears safe, making it a promising option for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The UNEEG SubQ device is unique because it offers a new way to monitor epilepsy by implanting a subscalp EEG. Unlike traditional treatments that rely on external EEG systems, which can be cumbersome and are used only during hospital visits, the UNEEG SubQ provides continuous, long-term monitoring right under the skin. This approach allows for more precise tracking of brain activity, potentially leading to better-tailored treatment plans. Researchers are excited because this could mean more accurate seizure detection and improved overall management of epilepsy.

What evidence suggests that the UNEEG SubQ device is effective for epilepsy?

Studies have shown that the UNEEG SubQ device improves seizure tracking and monitoring in people with epilepsy. Research indicates that this device enables continuous brain activity recording, lasting for years. This ongoing recording better documents seizures, especially for those unresponsive to medication. In a previous study, 73% of users found the device manageable over a long period, demonstrating that most people could use it comfortably. These findings suggest that the UNEEG SubQ device could enhance understanding and management of epilepsy by providing more detailed seizure information. Participants in this trial will receive the UNEEG SubQ device to evaluate its effectiveness in seizure monitoring. ^{2 4 6 7 8}

Who Is on the Research Team?

Benjamin Brinkmann, PhD

Principal Investigator

Mayo Clinic

Gregory A Worrell, MD, PhD

Principal Investigator

Mayo Clinic

Jamie J Van Gompel, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults aged 18-75 with temporal lobe epilepsy, who've had video-EEG monitoring in the last 3 years and experience at least two distinct seizures monthly. Participants must be medically stable, not require an MRI for two years, able to follow study procedures, and use contraception if applicable. Those with unstable medication doses, high seizure frequency, substance abuse history or psychiatric hospitalization within two years are excluded.

Inclusion Criteria

I have temporal lobe epilepsy and had a video-EEG in the last 3 years.

I am 18-75, can make medical decisions, follow treatment plans, and speak/read English.

My seizures have a specific pattern and involve the temporal lobe, confirmed by EEG.

Exclusion Criteria

My epilepsy medication doses have changed recently, or I've had many seizures lately.

Subject needs to have an MRI during the study period, has a substance abuse history within the past two years, participated in another drug or device trial within the past 30 days, or been hospitalized for a psychiatric condition within the past two years

I do not have any conditions or situations that would prevent safe participation in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Monitoring

Participants are implanted with the UNEEG SubQ device and monitored for surgical and device-related adverse events

1 week

1 visit (in-person)

Treatment and Monitoring

Participants use seizure forecasts based on subscalp EEG and are monitored for quality of life and adverse events

12 months

Regular visits (in-person and virtual) at baseline, 6 months, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• UNEEG SubQ device

Trial Overview The trial is testing the UNEEG SubQ device's ability to forecast seizures using subscalp EEG data. It aims to assess how safe and practical it is for people with epilepsy to use this technology as a way of predicting when they might have a seizure.

How Is the Trial Designed?

Group I: subscalp EEG Experimental Treatment 1 Intervention

All study subjects will be implanted with the UNEEG SubQ device.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. uneeg.com uneeg.com/

UNEEG medical ultra long-term EEG monitoring UNEEG EpiSight is the second generation of our breakthrough solution in epilepsy management - one that enables continuous, subcutaneous EEG recording for years ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40492935/

Protocol for a prospective multicentre interventional trial The aim of this study is to investigate whether ultra long-term subcutaneous EEG improves seizure documentation and disease monitoring in people with drug- ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/epi4.70064

Real world testing and cost‐effectiveness analysis of ... The aim of this study is to investigate whether ultra long-term subcutaneous EEG improves seizure documentation and disease monitoring in people with drug- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04526418

Evaluation of the 24/7 EEG SubQ System for Ultra Long- ... The present study is a 12-week open-label, prospective study with a paired, comparative design for pivotal evaluation of the safety and effectiveness of the 24 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589986425000413

Ultra-long-term subcutaneous EEG recordings in ten ... 4.1.​​ In 2019, the 24/7 EEG™ SubQ was used to record ultra-long EEG in nine epilepsy patients, achieving a compliance of 73 % (range 45–91 %), which is notably ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11601716/

Real-world epilepsy monitoring with ultra long-term ... Novel subcutaneous electroencephalography (sqEEG) systems enable prolonged, near-continuous cerebral monitoring in real-world conditions.

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000209428

Feasibility, Safety, and Performance of Full-Head Subscalp ... Recording full-head subscalp EEG for localization and monitoring purposes is feasible up to 9 days in humans using minimally invasive techniques.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/epi.18644

Unilateral ultra long‐term subcutaneous EEG monitoring in ... Here we show that a minimally invasive unilateral subcutaneous 24/7 EEG device can reliably detect convulsive and most (90%) absence seizures in ...