Vagus Nerve Stimulation for the Treatment of Medically Intractable SeizuresResults of a 1-Year Open-Extension Trial
Martin C. Salinsky, MD;
Basim M. Uthman, MD;
Ruzica K. Ristanovic, MD;
J. F. Wernicke, MD;
W. Brent Tarver, MS;
Vagus Nerve Stimulation Study Group
Arch Neurol. 1996;53(11):1176-1180.
Abstract
Background
Chronic vagus nerve stimulation (VNS) continues to be evaluated as an adjunctive treatment for medically intractable seizures. A previous randomized controlled trial of 114 patients demonstrated a significant decrease in seizure frequency during 3 months of VNS at effective stimulation levels.
Objective
To evaluate the efficacy of 1 year of VNS therapy for the treatment of medically refractory partial seizures and the relationship between initial and longterm response.
Patients and Methods
All patients exiting the randomized controlled study of VNS for treatment of medically refractory partial seizures were offered indefinite treatment extension as part of an open-label trial. One hundred (88%) of 114 patients completed 12 months of VNS treatment at effective stimulation levels. Fourteen patients discontinued VNS treatment prior to 1 year, principally because of the treatment's lack of efficacy. These 14 patients were retained in the present analysis using an intent-to-treat approach. Antiepileptic drug use was monitored throughout the trial. Seizure frequency was analyzed in 4 sequential 3-month treatment periods.
Results
Compared with pretreatment baseline, there was a significant decrease in seizure frequency during each of the 3-month treatment periods. Seizure frequency was reduced by a median of 20% during the first 3 months of VNS treatment and by 32% during stimulation months 10 through 12. Response during the first 3 months of VNS treatment was a statistically significant predictor of response at months 10 through 12. The observed reduction in seizure frequency was not explained by overall changes in antiepileptic drug use.
Conclusions
The results indicate that VNS remains an effective adjunctive therapy for medically refractory partial seizures over a period of at least 1 year. Response during the first 3 months of treatment is predictive of longterm response.
Author Affiliations
From the Oregon Health Sciences University Epilepsy Center, Portland (Dr Salinsky); Department of Neurology, University of Florida, Gainesville (Dr Uthman); Department of Neurology, Rush-Presbyterian-St Luke's Medical Center, Chicago, Ill (Dr Ristanovic); and Cyberonics Inc, Webster, Tex (Dr Wernicke and Mr Tarver). A complete list of members of the Vagus Nerve Stimulation Study Group appears on page 1180.
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