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

Open to people ages 18-75

• 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.

• 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).