Ensayos clínicos

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 4/2/2024. Questions regarding updates should be directed to the study team contact.