Epilepsy Nervous System Diseases Epilepsy
Conditions
Interventions
Intervention:
VNS therapy is implanted under the left clavicle and typically this is done in 1 hour. The electrode is tunneled from the device sub-pectoral pocket to the left vagus nerve.
Control:
Sponsors
Cyberonics Europe SA/NV (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for enrolment in the study, patients must meet all of the following criteria: 1. Patient has confirmed partial onset seizures 2. Seizure activity is not adequately controlled by patient's current antiepileptic drug (AED) regimen 3. Patient is age 16 up to age 75, either sex 4. Patient is able to give accurate seizure counts and health outcomes information 5. Patient has previously failed at least 3 AEDs in single or combination use 6. During baseline, patient should take 1 AED 7. Patient should have confirmed epilepsy for a minimum of 2 years 8. Patient's AED regimen is stable for at least one month prior to enrolment 9. Patient has at least one partial onset seizure per month 10. Patients with an intelligence quotient (IQ) greater than or equal to 70 11. Patient or legal guardian understands study procedures and has voluntarily signed an informed consent in accordance with institutional policies
Exclusion criteria
Exclusion criteria: Patients with any of the following will not be eligible for enrolment: 1. Patient has a history of pseudoseizures 2. Patient has had more than one episode of status epilepticus (SE) in the past 12 months 3. Patient has idiopathic or difficult to classify seizures 4. Patient has ever received direct brain stimulation (cerebella or thalamic) for treatment of epilepsy 5. Patient has had a unilateral or bilateral cervical vagotomy 6. Patient has a history of non-compliance for seizure diary completion 7. Patient has taken an investigational drug within a period of 3 months prior to inclusion 8. Patient is currently using another investigational medical device 9. Patient has a significant cardiac or pulmonary condition currently under treatment 10. Patient has other progressive neurological disease, significant central nervous system (CNS) disease or injury, or cervical fracture that makes implantation of the VNS therapy system difficult 11. Patient has previously undergone brain surgery 12. Patient has a demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator 13. Patient currently lives more than two hours away from the study site or plans to relocate to a location distant from the study site within one year of enrolment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To show over time that the efficacy of adding VNS therapy is non-inferior to the efficacy obtained with best medical practice 2. To show over time superiority of VNS therapy in health outcomes compared with best medical practice using the 89-item Quality of Life in Epilepsy (QOLIE-89) inventory | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the efficacy and health outcomes of both treatment arms using other assessments focused on: 1. Seizure freedom 2. Mood 3. Safety/tolerability 4. Drug changes 5. Retention rate 6. Compliance | — |
Countries
Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, United Kingdom
Outcome results
None listed