24/7 EEG Monitoring for Temporal Lobe Epilepsy

No longer recruiting at 14 trial locations

Overseen By Pia Nordmand, Director

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNEEG Medical A/S

Must not be taking: Antiplatelets, Anticoagulants, NSAIDs, Chemotherapeutics

Disqualifiers: Pregnancy, Skeletal deformities, Infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

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 device, the 24/7 EEG™ SubQ system, to evaluate its effectiveness in tracking seizures in individuals with temporal lobe epilepsy. Researchers will compare its performance to standard video-EEG tests and patient seizure diaries over 12 weeks. The goal is to determine if this device can safely and effectively monitor seizures outside a hospital setting. Individuals with uncontrolled seizures related to the temporal lobe, who have previous evidence of this condition, such as EEG or MRI findings, might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance seizure monitoring.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking certain drugs like antiplatelets, anticoagulants, chemotherapeutics, or NSAIDs more than twice a week, you may not be eligible to participate.

What prior data suggests that the 24/7 EEG™ SubQ system is safe for monitoring temporal lobe epilepsy?

Research has shown that the 24/7 EEG™ SubQ system is generally easy for patients to use. One study found that using this device at home for three months was practical and well-received by participants. No major safety issues emerged, indicating that the system is safe for long-term use.

Overall, this device provides a dependable way to monitor seizure activity without significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 24/7 EEG™ SubQ system because it offers continuous, long-term monitoring of brain activity for people with temporal lobe epilepsy, which is a big step up from the standard short-term inpatient video-EEG sessions. Unlike traditional methods, this system can be used outside a hospital setting, providing a more convenient and less invasive way to capture seizures as they happen in daily life. This could lead to a more accurate diagnosis and better treatment adjustments, potentially improving quality of life for those affected by this condition.

What evidence suggests that the 24/7 EEG™ SubQ system is effective for temporal lobe epilepsy?

Research has shown that the 24/7 EEG™ SubQ system, used by participants in this trial, effectively monitors seizures in individuals with temporal lobe epilepsy. Studies have found that this system enables nearly continuous brain monitoring in daily life. It records seizure activity over extended periods, helping to identify patterns and frequency. This capability is crucial because it provides more accurate information than traditional short-term EEGs typically conducted in hospitals. By tracking seizures over weeks or months in real-world conditions, the system offers a new approach to better understand and manage epilepsy. ^{1 2 5 6 7}

Who Is on the Research Team?

Michael Gelfand

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with temporal lobe epilepsy who have uncontrolled seizures and evidence of temporal seizure focus. They must be scheduled for clinical monitoring within 12 weeks post-implant, able to consent, and complete all study procedures. Excluded are those at high risk of surgical complications or on frequent medication like antiplatelets or NSAIDs.

Inclusion Criteria

My seizures are related to the temporal lobe of my brain.

I have seizures that my medication cannot control.

I am scheduled for a hospital stay to monitor my epilepsy within 3 months after getting a UNEEG™ SubQ implant.

Exclusion Criteria

I have bone damage or deformities where they plan to place the implant that could cause issues.

I frequently take medication like blood thinners, chemotherapy drugs, or anti-inflammatory drugs.

You have a cochlear implant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Monitoring

Participants undergo simultaneous inpatient video-EEG monitoring in the Epilepsy Monitoring Unit for comparison with the 24/7 EEG™ SubQ system

3-14 days

Hospitalized

Outpatient EEG Recording

Participants use the 24/7 EEG™ SubQ system for ultra long-term recording and self-report seizures in log books

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the main recording period

4 weeks

Long-term Safety Monitoring

Participants are monitored for adverse events over an extended period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 24/7 EEG™ SubQ system

Trial Overview The trial tests the 24/7 EEG™ SubQ system against standard video-EEG in a hospital setting and patient-reported seizure logs over a period of 12 weeks. It aims to assess safety and effectiveness in recording long-term EEG data for patients with temporal lobe epilepsy.

How Is the Trial Designed?

Group I: 24/7 EEG™ SubQ System Experimental Treatment 1 Intervention

To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data.

24/7 EEG™ SubQ system is already approved in European Union for the following indications:

Approved in European Union as 24/7 EEG SubQ for:

• Epilepsy involving the temporal lobe region

Who Is Running the Clinical Trial?

UNEEG Medical A/S

Lead Sponsor

Trials

16

Recruited

320+

Published Research Related to This Trial

Sub-scalp electroencephalography (ssEEG) is a promising technology for ultra-long-term EEG recordings, with potential applications in various areas such as seizure quantification, characterization, and localization, as well as sleep medicine and biomarker discovery.

Different ssEEG devices have unique strengths and limitations, with some designed for unilateral or bilateral recordings and others capable of responsive stimulation, highlighting the need for tailored designs to optimize their utility in epilepsy evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sub-scalp electroencephalography: A next-generation technique to study human neurophysiology. Haneef, Z., Yang, K., Sheth, SA., et al.[2022]

Serious adverse events (SAEs) during long-term video-electroencephalography monitoring (LTM) occur in about 10% of patients, including severe complications like generalized tonic-clonic seizures, injuries, and even sudden unexpected death in epilepsy (SUDEP).

The risk of SAEs may be increased by the withdrawal of antiepileptic drugs (AEDs), and current EMU practices often do not adhere to recommended guidelines for continuous supervision, highlighting a need for improved organization and staff training in epilepsy monitoring units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' safety in the epilepsy monitoring unit: time for revising practices. Rheims, S., Ryvlin, P.[2014]

The 'Oxford' ambulatory nontelemetry EEG monitoring device has proven to be a useful and cost-effective tool for monitoring brain and heart activity in patients outside of a hospital setting.

Selecting patients with potential seizure disorders and focusing on temporal lobe recordings can enhance the diagnostic accuracy of this monitoring method, indicating the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of ambulatory EEG monitoring. Green, J., Scales, D., Nealis, J., et al.[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]

A retrospective review of 198 monitoring sessions involving 187 patients showed that the complication rate during video-EEG monitoring with subdural grid electrodes decreased significantly over time, from 19% in the last 5 years to 13.5% in the last 3 years, with most complications being transient.

Complications were more likely to occur with left-sided grid insertion, longer monitoring durations (especially over 10 days), and when using more than 60 electrodes, highlighting the importance of careful planning in invasive monitoring procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of invasive video-EEG monitoring with subdural grid electrodes. Hamer, HM., Morris, HH., Mascha, EJ., et al.[2022]

The authors present a novel surgical technique for placing subdural strip electrodes in patients with temporal lobe epilepsy (TLE) that allows for safe coverage of the temporal lobe without the need for craniotomy or complex navigation systems.

This technique utilizes fluoroscopic guidance to effectively lateralize and localize seizure foci within the temporal lobe, potentially improving the monitoring process for patients requiring invasive electroencephalography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insertion of subdural strip electrodes for the investigation of temporal lobe epilepsy. Technical note. Steven, DA., Andrade-Souza, YM., Burneo, JG., et al.[2007]

Subcutaneous EEG recordings show high similarity to scalp EEG recordings in detecting epileptiform signals, suggesting they can be a viable option for long-term epilepsy monitoring in real-life conditions.

The study indicates that the effectiveness of subcutaneous EEG is influenced by the distance between electrodes, highlighting the need for careful positioning to ensure accurate monitoring of localized brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High similarity between EEG from subcutaneous and proximate scalp electrodes in patients with temporal lobe epilepsy. Weisdorf, S., Gangstad, SW., Duun-Henriksen, J., et al.[2019]

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]

In a study of 1000 EEG reports, adverse events occurred in 13.1% of cases, with seizures reported in 60 instances, indicating that while seizures can occur, they are generally brief and manageable during EEG procedures.

Patients with idiopathic generalized epilepsy and photosensitivity experienced a higher incidence of seizures during activation procedures, suggesting that these techniques may be more risky for certain individuals, which is important for informed consent regarding EEG testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures and adverse events during routine scalp electroencephalography: a clinical and EEG analysis of 1000 records. Angus-Leppan, H.[2008]

Chronic subdural EEG monitoring in 31 children with intractable seizures effectively localized seizure foci, leading to surgical interventions in 20 patients, demonstrating its utility in pediatric epilepsy management.

The procedure was found to be safe, with only one complication (a subdural hematoma), indicating that chronic subdural monitoring is a reliable method for mapping brain functions like speech and motor areas in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of subdural grids and strip electrodes to identify a seizure focus in children. Adelson, PD., Black, PM., Madsen, JR., et al.[2022]

Citations

1. 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 ...

2. 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.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1388245722008409

Detecting temporal lobe seizures in ultra long-term ... Ultra long-term subcutaneous EEG offers a novel option for the recording of electrographic epileptic seizures in everyday life.

4. mayo.edu mayo.edu/research/clinical-trials/cls-20508098

Evaluation of the 24/​7 EEG SubQ System for Ultra Long- ... The main purpose of the study is to demonstrate the performance and safety of the 24/7 EEG™ SubQ system as a reliable ultra long-term recorder ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/epi.18566

Real‐world epilepsy monitoring with ultra‐long‐term ... Data collection commenced 1–2 weeks after implantation. Patients were instructed to wirelessly connect the 24/7 EEG SubQ external logging device ...

6. epilepsy.com epilepsy.com/deviceapedia/247-eeg%E2%84%A2-subq

24/7 EEG™ SubQ The system comes with software for analysing and visualizing EEG data. It gives an easy overview of seizure activity identified by EEG patterns.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6899579/

Ultra‐long‐term subcutaneous home monitoring of ... The study shows that home monitoring for up to 3 months with a subcutaneous EEG device is feasible and well tolerated.