Vagus Nerve Stimulation (VNS) Therapy has been approved marked for the treatment of epilepsy since 1994. This post-market study is designed to follow the clinical course and outcomes for patients with refractory seizures treated with adjunctive VNS Therapy. Seizure frequency, seizure severity, side effects burden, depressive symptoms, global impressions, and health care utilization will be evaluated. The results of this study will provide data to guide physicians and their patients in the use of VNS Therapy for patients with refractory seizures who have failed initial trials of anti-epileptic drug (AED) therapy. The data being collected is not for the purposes of confirmatory assessment.
Minimum ages eligible for the E-103 study is at least 7 years outside of the US, consistent with "Non-US" labeling and 12 years for sites in the US.
Study Type
OBSERVATIONAL
Enrollment
124
Emory Healthcare
Atlanta, Georgia, United States
University of Illinois College of Medicine at Peoria
Peoria, Illinois, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Cornell University
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Covenant Hospital
Lubbock, Texas, United States
St. Luke's Milwaukee
Milwaukee, Wisconsin, United States
UZ Gasthuisberg
Leuven, Belgium
Epilepsieklinik Tabor - Ladeburger Straße 15
Berlin, Germany
Albert-Ludwigs-Universität Freiburg
Freiburg im Breisgau, Germany
...and 10 more locations
Two-Year Clinical Follow-up
To follow the clinical course of patients with refractory seizures treated with adjunctive VNS Therapy over a two-year follow-up period.
Time frame: 27 months
Efficacy and Safety
1. To evaluate over time the efficacy of best medical practice with adjunctive VNS Therapy in patients with refractory seizures. 2. To evaluate over time the safety and tolerability of best medical practice with adjunctive VNS Therapy in patients with refractory seizures.
Time frame: 27 months
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