External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial

Francisco Gil-López*, Teresa Boget, Isabel Manzanares, Antonio Donaire, Estefanía Conde-Blanco, Eva Baillés, Luis Pintor, Xavier Setoaín, Núria Bargalló, Judith Navarro, Jordi Casanova, Josep Valls, Pedro Roldán, Jordi Rumià, Georgina Casanovas, Gema Domenech, Ferrán Torres, Mar Carreño

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background: External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE). Objective: To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability. Methods: Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability. Results: Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by −43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed. Conclusions: ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques. Classification of evidence: This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.

Original languageAmerican English
Pages (from-to)1245-1253
Number of pages9
JournalBrain Stimulation
Volume13
Issue number5
DOIs
Publication statusPublished - 1 Sep 2020

Keywords

  • Clinical trial
  • Epilepsy
  • Epileptogenic zone
  • Neurostimulation
  • Trigeminal nerve stimulation

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