Concurrent brain-responsive and vagus nerve stimulation for treatment of drug-resistant focal epilepsy

Epilepsy Behav. 2022 Apr:129:108653. doi: 10.1016/j.yebeh.2022.108653. Epub 2022 Mar 16.


Objective: Clinical trials of a brain-responsive neurostimulator, RNS® System (RNS), excluded patients with a vagus nerve stimulator, VNS® System (VNS). The goal of this study was to evaluate seizure outcomes and safety of concurrent RNS and VNS stimulation in adults with drug-resistant focal-onset seizures.

Methods: A retrospective multicenter chart review was performed on all patients with an active VNS and RNS who were treated for a minimum of 6 months with both systems concurrently. Frequency of disabling seizures at baseline before RNS, at 1 year after RNS placement, and at last follow-up were used to calculate the change in seizure frequency after treatment. Data on adverse events and complications related to each device were collected.

Results: Sixty-four patients from 10 epilepsy centers met inclusion criteria. All but one patient received RNS after VNS. The median follow-up time after RNS implantation was 28 months. Analysis of the entire population of patients with active VNS and RNS systems revealed a median reduction in seizure frequency at 1 year post-RNS placement of 43% with a responder rate of 49%, and at last follow-up a 64% median reduction with a 67% responder rate. No negative interactions were reported from the concurrent use of VNS and RNS. Stimulation-related side-effects were reported more frequently in association with VNS (30%) than with RNS (2%).

Significance: Our findings suggest that concurrent treatment with VNS and RNS is safe and that the addition of RNS to VNS can further reduce seizure frequency.

Keywords: Complications; Drug-resistant epilepsy; Neuromodulation; Responsive neurostimulation; Seizure outcome; Vagus nerve stimulation.

Publication types

  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Brain
  • Drug Resistant Epilepsy* / therapy
  • Epilepsies, Partial* / therapy
  • Humans
  • Retrospective Studies
  • Treatment Outcome
  • Vagus Nerve
  • Vagus Nerve Stimulation* / adverse effects