The purpose of this study was to investigate a mechanism of action for the
effect of vagal nerve stimulation on reducing seizures in patients with com
plex partial epilepsy. The hypothesis tested was that vagal nerve stimulati
on has an antikindling effect on epilepsy. The databases of two large clini
cal trials (E03, E05) were accessed, and statistical methods were applied u
sing logarithmic transforms and regression analysis. Two parameters-duratio
n of a patient's epilepsy before entering the clinical trial and the patien
t's seizure density before entering the clinical trial-were used as markers
of subsequent seizure control during vagal nerve stimulation. In general,
there was not a good fit to the regression lines, and the slope of the line
s did not conform to the hypothesis. The hypothesis that vagal nerve stimul
ation may unkindle epileptic seizures was not supported.