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November 1996

Vagus Nerve Stimulation for the Treatment of Medically Intractable Seizures: Results of a 1-Year Open-Extension Trial

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.

Arch Neurol. 1996;53(11):1176-1180. doi:10.1001/archneur.1996.00550110128021

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.

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