A pilot study of the teratogenicity of vagus nerve stimulation in a rabbit model.

BACKGROUND: Vagus nerve stimulation (VNS) is approved for the adjunctive treatment of both refractory epilepsy and treatment-resistant depression. This study assessed the effect of VNS on fertility, teratogenicity, and neonatal morbidity in rabbits. METHODS: Ten female New Zealand white rabbits (test animals) were implanted with the VNS device. Ten additional female rabbits (surgical controls) received nonfunctional devices. Four additional female rabbits served as untreated controls and 10 male rabbits served for siring purposes. Test rabbits received VNS at 1 mA, 30 Hz, 500 microseconds, 30 seconds ON, 5 minutes OFF. Rabbits mated and were randomly assigned into 2 groups: those killed on day 28 and those proceeding through parturition. Groups were compared by using a 1-way analysis of variance with a Newman-Keuls Multiple Comparison post-hoc test. Differences between control and test animals were considered statistically significant if P