Conditions: Epilepsy Partial Epilepsy
Keywords: Epilepsy VNS Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 122
Healthy volunteers: yes

Brief summary:
This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmacoresistant partial epilepsy.

Detailed description:
This is a post-market medical device study. This study will compare best medical practice with or without adjunctive VNS Therapy in patients who are 16 years and older with pharmaco-resistant partial epilepsy. The Sponsor, Cyberonics, provides funding for this study. Patients are followed for 26 months, 24 of those months are following the initiation of treatment. No study sites will be permitted to enroll study subjects until Institutional Review Board (IRB)/Ethics Committee (EC) approval has been received.

Arms:
arm 1: VNS Therapy + Best Medical Practice arm 2: Best Medical Practice

Interventions: intervention 1: Vagal Nerve Simulation (VNS) Therapy intervention 2: Best Medical Practive
Intervention descriptions: intervention 1: VNS Therapy + Best Medical Practice including anti-epileptic drugs intervention 2: Best Medical Practice including anti-Epileptic Drugs

Protocol document: