Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients

An Open Prospective Randomised Long-Term Effectiveness Study, Comparing Best Medical Practice With or Without Adjunctive VNS Therapy in Patients 16 Years and Older With Pharmaco-resistant Partial Epilepsy

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.

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.

Inclusion Criteria:

• Patient has confirmed partial onset seizures.
• Seizure activity is not adequately controlled by patient's current AED regimen.
• Patient is between 16 and 75 years of age.
• Patient is able to give accurate seizure counts and health outcomes information. Patient is able to complete study instruments with minimal assistance.
• Patient has previously failed at least 3 AEDs in single or combination use.
• During baseline evaluation period, patient should take at least 1 AED.
• Patient should have confirmed epilepsy for a minimum of 2 years.
• Patient's AED regimen is stable for at least 1 month prior to enrolment.
• Patient has at least 1 objective partial onset seizure per month during the 2 months prior to enrolment.
• Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies.

Exclusion Criteria:

• Patient has pseudoseizures or a history of pseudoseizures.
• Patient has idiopathic generalised epilepsy or unclassified epilepsy.
• Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy.
• Patient has had a unilateral or bilateral cervical vagotomy.
• Patient has a history of non-compliance with the completion of a seizure diary.
• Patient has taken an investigational drug within a period of 3 months prior to inclusion.
• Patient is currently using another investigational medical device.
• Patient has a significant cardiac or pulmonary condition currently under treatment.
• Patient has previously undergone brain surgery.
• Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator.
• Patient currently lives more than 2 hours from the study site or plans to relocate to a location more than 2 hours from the study site within one year of enrolment in the Study.