Twenty patients (11F/9M) with a mean age of 40 years (range 8–61), who were considered unsuitable candidates for resective surgery, were implanted with a VNS Therapy™ Demipulse Model 103. Mean monthly seizure frequency reduction and side effects were evaluated 1 year after implantation.
Mean monthly seizure frequency decreased significantly from 54 seizures/month (SEM 30; range 1–555) before treatment to 33 (SEM 24, range 0–445) following 12 months of treatment (p < 0.05). Seven patients (39 % ) were considered responders with a reduction in seizure frequency of more than 50 % . One of those seven patients became seizure free. Side effects were stimulation-related tingling sensation in the throat and/or hoarseness, a painful sensation in the left neck or ear region and a lead breakage In addition; one case of SUDEP was reported.
Patients treated with VNS Therapy™ Demipulse generators proved to have a significant decrease in seizure frequency. In this patient group, VNS was well tolerated. The main technical advances are the decrease in size and improved options for battery life follow-up.