EASEE® System Pivotal Study for the United States of America

EASEE® System Pivotal Study for the United States of America

The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are:

1. Is the percentage reduction of monthly seizure rate larger in the Intervention group than in the Control group at the end of the Blinded Phase?
2. Is the use of EASEE(R) System safe after up to 28 and up to 84 days?

Participants will be asked to:

• Complete a seizure diary for the duration of the clinical trial
• Attend study visits for 20 months of their clinical trial participation
• Undergo EASEE(R) System implant
• Not be aware if neurostimulation is delivered during the Blinded Phase (6 months)
• Receive neurostimulation for at least 12 months

Inclusion Criteria:

• Adult between 18-75 years of age
• Diagnosis of drug-resistant focal epilepsy
• At least four (4) observable seizure manifestations per month
• Stable anti-seizure medication regimen

Exclusion Criteria:

• Diagnostic of non-epileptic seizures
• Active idiopathic generalized epilepsy
• Recent status epileptics (<12 months)
• Clinically significant or unstable medical condition
• Active psychosis, major depression, suicidal ideation (<6 months)
• Pregnancy
• Implanted with brain stimulation device or active Vagus Nerve Stimulation