Transcutaneous vagal nerve stimulatio (t-VNS): An adjunctive treatment option for refractory epilepsy.

PURPOSE

The aim of this trial was to investigate the efficacy and safety of transcutaneous vagal nerve stimulation (t-VNS) in the palliative treatment of drug resistant epileptic patients ineligible for surgery.

METHODS

Twenty adult patients received four hours of t-VNS per day for six months (T1), followed by a two-month washout period (T2). The frequency and type of seizures recorded at T1 and T2 were compared with those occurring in the three months preceding study entry (T0). Responders (>30% reduction in the total number of seizures) subsequently received two hours of t-VNS per day for further six months (T3). All patients underwent electroencephalography (EEG) and completed the Quality of Life in Epilepsy questionnaire at baseline and T1.

RESULTS

At T1 six patients were considered responders. In these patients, at T3 the average reduction in seizure frequency was 60% compared to T0 (p = 0.043), and 51% compared to T2 (p = 0.043). Responders had more often seizures with falls (5 of 6; 83.3%) compared with non-responders (3 of 14; 21.4%) (p = 0,010) and t-VNS reduced their frequency by a percentage ranging from 47.5 to 100%. There was no change in responders' EEG findings after stimulation. At the end of the trial, three responders continued t-VNS, one implanted VNS.

CONCLUSIONS

t-VNS had no or minimal side effects and significantly reduced seizures in about one third of the enrolled patients. Further studies should be planned to assess whether t-VNS is a suitable tool to predict the efficacy of implanted VNS.