24/7 EEG Monitoring for Temporal Lobe Epilepsy

Recruiting at 11 trial locations

Overseen By Gregory Worrell

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

110 Participants Needed

Trial Summary

What is the purpose of this trial?

The 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording. 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 24/7 EEGTM SubQ system in subjects with epilepsy involving the temporal lobe region . 2-5 sites in Europe Up to 10 sites in US

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 data supports the effectiveness of the 24/7 EEG SubQ treatment for temporal lobe epilepsy?

Research shows that subcutaneous EEG recordings, like those used in the 24/7 EEG SubQ system, are very similar to traditional scalp EEG recordings in detecting epilepsy-related brain activity. This similarity suggests that the 24/7 EEG SubQ system can effectively monitor seizures in real-life conditions, providing continuous and reliable data for managing temporal lobe epilepsy. ^{1 2 3 4 5}

Is the 24/7 EEG Monitoring for Temporal Lobe Epilepsy safe for humans?

The 24/7 EEG Monitoring system has been tested for long-term use in epilepsy patients, and the research suggests it is generally safe for humans. The study involving nine patients over 490 days did not report significant safety concerns, indicating it is feasible for home monitoring. ^{2 3 6 7 8}

How is the 24/7 EEG SubQ system treatment different from other treatments for temporal lobe epilepsy?

The 24/7 EEG SubQ system is unique because it allows for continuous, long-term monitoring of brain activity through subcutaneous (under the skin) electrodes, providing patients with more mobility and discretion compared to traditional scalp EEGs. This system is designed for real-life, outpatient use, making it more convenient for patients to monitor their epilepsy over extended periods. ^{1 2 4 9 10}

Research Team

Michael Gelfand

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

High similarity between EEG from subcutaneous and proximate scalp electrodes in patients with temporal lobe epilepsy. [2019]

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

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

3. 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]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Sub-scalp electroencephalography: A next-generation technique to study human neurophysiology. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Use of subdural grids and strip electrodes to identify a seizure focus in children. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Patients' safety in the epilepsy monitoring unit: time for revising practices. [2014]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Complications of invasive video-EEG monitoring with subdural grid electrodes. [2022]

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

Insertion of subdural strip electrodes for the investigation of temporal lobe epilepsy. Technical note. [2007]

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

Clinical utility of ambulatory EEG monitoring. [2019]