Study comparing best medical practice with or without vagus nerve stimulation (VNS) therapy in pharmacoresistant partial epilepsy patients

Completed

• Conditions: Epilepsy; Nervous System Diseases

• Registration Number: ISRCTN51185809
• Lead Sponsor: Cyberonics Europe SA/NV (Belgium)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-18
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 366

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified