TRIGEMINAL NERVE STIMULATION FOR EPILEPSY: LONG-TERM FEASIBILITY AND EFFICACY

Abstract

Neurostimulation has emerged as a viable alternative for intractable epilepsy. Trigeminal nerve stimulation (TNS), a novel form of neurostimulation, has an antiepileptic effect in a rodent model.1 The superficial location of trigeminal branches allows for minimally invasive approaches, allowing assessment of response prior to a permanent device.2 We report the long-term safety and efficacy of external TNS for epilepsy. ### Methods. Research committee approval was obtained for an open study of external TNS in epilepsy. Informed consent was obtained before enrollment. Inclusion/exclusion criteria were age 18–65 years, ≥3 complex-partial/generalized tonic-clonic seizures/month, no progressive medical conditions, and exposure to ≥2 antiepileptic drugs (AEDs). Subjects enrolled in a 4-week pretreatment baseline, and were evaluated at 1, 2, 3, 6, and 12 months. AEDs remained unchanged unless essential for patient safety. Neurostimulation was initially supplied using the analog EMS Model 400, and later a digital EMS model 7500.2 Stimulation settings were as follows: frequency 120 Hz, 250 μs, ≤30 seconds on, ≤30 seconds off for 12–24 hours/day, and 1.25-inch disposable, silver-gel, adhesive electrodes were utilized, spaced 2 inches …