Clinical Trials

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).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/14/2024. Questions regarding updates should be directed to the study team contact.