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

 1. antiplatelets

 2. anticoagulants

 3. chemotherapeutics

 4. 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).