Study Comparing Best Medical Practice With or Without VNS Therapy in Pharmacoresistant Partial Epilepsy Patients
Condition: Epilepsy; Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Vagal Nerve Simulation (VNS) Therapy; Best Medical Practive
Intervention description: VNS Therapy + Best Medical Practice including anti-epileptic drugs; Best Medical Practice including anti-Epileptic Drugs
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Epilepsy; VNS Therapy

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.
    

Eligibility criteria:

        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.