Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy

Study Overview
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Brief Summary
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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 temporal lobe epilepsy. 2-5 sites in Europe Up to 5 sites in US, or up to 10 sites if approval granted.

Official Title
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Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy An Open-label, Prospective, Paired, Comparative Study

Conditions
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Epilepsy

Intervention / Treatment
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* Device: 24/7 EEG™ SubQ system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18-75 years old. Semiology of seizures compatible with temporal lobe involvement Paraclinical findings supporting temporal seizure focus. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT). Uncontrolled epileptic seizures. Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant. Subject is willing and able to provide written informed consent. Subject is able to complete all study-required procedures, assessments and follow-up. Exclusion Criteria: Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease. Subject receives frequent (more than 2 days per week) treatment with drugs of the following types: antiplatelets anticoagulants chemotherapeutics non-steroid anti-inflammatory drugs (NSAID) Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement. Subject has an active deep brain stimulation device. Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant. Subject has a cochlear implant(s).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: open-label, prospective study with a paired comparative design for pivotal evaluation of the satety and effectiveness of the 24/7 EEC SubQ system in subjects with temporal lobe epilepsy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 24/7 EEG™ SubQ System<br>To demonstrate the electrographic seizure recording effectiveness of the 24/7 EEG™ SubQ system by comparison to simultaneous inpatient video-EEG data. | Device: 24/7 EEG™ SubQ system<br>* Electrographic seizure recording sensitivity of an ipsilaterally implanted 24/7 EEG™ SubQ system: proportion of identified ipsilateral seizures as compared to ipsilateral video-EEG during admission to the Epilepsy Monitoring Unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of seizures | numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG). | comparasion in EMU for 3-14 days period, where patients are hospitalized. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse event | safety reporting | 2 years |