A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl

Prior treatment

• Prior cervical vagotomy.
• Prior implant with vagus nerve stimulation device.
• Prior therapeutic brain surgery for epilepsy within the last 6 months prior to NAO.VNS implantation.
• Receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation.
• Currently receiving another investigational treatment.

Other illness

• Unstable medical condition likely to precipitate seizures and make it difficult to evaluate efficacy.
• Progressive neurological disease.
• Significant cardiac or pulmonary disease under treatment.
• History of noncompliance for seizure diary completion.
• Current active treatment of epilepsy with cerebellar or thalamic stimulation.
• Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor) are allowed).

Other

• Pregnancy.
• Patient with Vocal Cord Palsy (VCP), including unilateral, whatever the side.
• Diabetic patients and all patients with a known vagal neuropathy.
• Patient currently participating in another clinical investigation, without explicit consent of the Sponsor (non-interventional registries are allowed).

• Ability to understand the Informed Consent Form (ICF) and the study procedures and provide written consent or, in case of cognitive impairment, be the legal ward of a person who is able and willing to provide written consent.
• Subjects diagnosed with Drug Resistant Epilepsy (DRE) and candidate for VNS treatment
• Ability of subjects or, in the case of cognitive impairment, their caregiver, to accurately count seizures and complete seizure diaries.
• Adult subjects, age ≥ 18.
• Willingness of subjects or, in the case of cognitive impairment, their caregiver, to charge the NAO.VNS system with the Smart Charger on a weekly basis.
• Subjects' willingness to follow the protocol procedures. For example, subject should have a careful seizure diary completion according to standard of care to ensure 8 weeks of data available by time of implant.
• Female subjects of childbearing age using acceptable methods of birth control (abstinence considered acceptable).