Journal
EPILEPSY & BEHAVIOR
Volume 29, Issue 2, Pages 416-419Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.yebeh.2013.08.014
Keywords
Vagus nerve stimulation; Refractory epilepsy; Treatment
Categories
Funding
- Bial
- UCB
- Eisai
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Vagus nerve stimulation (VNS) is an accepted therapy for the treatment of drug-resistant epilepsy. A new VNS system (FitNeS; manufactured by BioControl Medical (B.C.M.) Ltd., Yehud, Israel) was implanted in 5 patients with refractory focal epilepsy. The system is composed of a programmable pulse generator and a cuff electrode that is able to provide unidirectional stimulation, both of which are implanted in the left chest and in the neck, respectively. FitNeS is based on the CardioFit vagus nerve stimulation system, which is intended for the treatment of heart failure and which is currently in a randomized controlled phase III clinical trial. Long-term stimulation in the 5 patients resulted in a 50% seizure reduction in 2 patients, 25% in 2 patients, and no effect in one patient, with few reports concerning side effects. There were no complaints of hoarseness at levels of stimulation below 2 mA nor were there any reports of dysphagia or cough. The lack of perceived stimulation effects might finally allow for the design of a truly blinded randomized controlled study to evaluate the efficacy of VNS compared to placebo. (C) 2013 Elsevier Inc. All rights reserved.
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