Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Temporal Lobe Epilepsy
Study Details
Study Description
Brief Summary
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 years (from study start up to closure) 5-6 sites in the United States/Europe.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 24/7 EEG™ SubQ System 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
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
|
Outcome Measures
Primary Outcome Measures
- number of seizures [comparasion in EMU for 3-14 days period, where patients are hospitalized.]
numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).
Secondary Outcome Measures
- adverse event [2 years]
safety reporting
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject is 18-75 years old.
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Semiology of seizures compatible with temporal lobe involvement
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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).
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Uncontrolled epileptic seizures.
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Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
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Subject is willing and able to provide written informed consent.
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Subject is able to complete all study-required procedures, assessments and follow-up.
Exclusion Criteria:
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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.
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Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:
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antiplatelets
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anticoagulants
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chemotherapeutics
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non-steroid anti-inflammatory drugs (NSAID)
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Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
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Subject has an active deep brain stimulation device.
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Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant.
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Subject has a cochlear implant(s).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Phoenix | Arizona | United States | 85054 |
| 2 | University of Pennsylvenia | Philadelphia | Pennsylvania | United States | 19104 |
| 3 | Universität Klinikum Freibrug | Freiburg | Germany | 79106 |
Sponsors and Collaborators
- UNEEG Medical A/S
Investigators
- Principal Investigator: Jay Pathmanathan, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- U002