An open Prospective randomised Long-term Effectiveness study, comparing adjunctive vagus nerve stimulation (VNS) therapy with best medical practice in patients with pharmaco-resistant partial epilepsy aged 16 and above

Cyberonics Europe SA/NV (Belgium)0 个研究点目标入组 366 人开始时间: 2005年2月18日最近更新: 2016年10月17日

适应症

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•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

•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

发起方

Cyberonics Europe SA/NV (Belgium)