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

Date de début de l'étude : 1 février 2006

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.