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Commentary Stimulatory devices offer a novel approach for the treatment of refractory partial seizures. Both peripheral and central stimulatory devices that provide either continuous or responsive stimulation have been studied. Currently the only approved device is the vagus nerve stimulator (VNS). Stimulatory devices may provide a safe and well-tolerated means of reducing seizures for patients with refractory seizures. Trigeminal nerve stimulation (TNS) is a neuromodulatory device that has been studied in animal and pilot clinical trials. The original article investigating its potential antiepileptic properties was an animal study evaluating its effect on pentylenetetrazole-induced seizure activity in awake rats (1). Continuous unilateral stimulation of the trigeminal nerve reduced electrographic seizure severity and duration activity in a frequency-dependent fashion at frequencies >100 Hz. Bilateral trigeminal stimulation was more effective than unilateral stimulation. A proof-of-concept clinical trial investigated safety and efficacy among seven subjects using transcutaneous stimulation of the infraorbital and supraorbital branches of the trigeminal nerve (2). In this study, TNS was well tolerated, and four of seven subjects who completed ≥3 months had a ≥50% reduction in seizure frequency. Another study evaluated its effect in depression and found significant improvement in clinicianand individual-rated depression scales among five subjects (3). There has not previously been a randomized, blinded, controlled trial among persons with refractory epilepsy. DeGiorgio and colleagues completed a phase-2 randomized, double-blind, multicenter trial evaluating external TNS (eTNS) among subjects with drug-resistant partial-onset epilepsy (having two or more complex partial or generalized tonic seizures per month for 2 consecutive months) (4). Subjects were randomized to either active treatment (frequency of 120 Randomized Controlled Trial of Trigeminal Nerve Stimulation for Drug-Resistant Epilepsy.

Trigeminal Nerve Stimulation May Not be Effective for the Treatment of Refractory Partial Seizures