Vagus nerve stimulation therapy in people with drug-resistant epilepsy (CORE-VNS): rationale and design of a real-world post-market comprehensive outcomes registry.

Sen A, Verner R, Valeriano JP, Lee R, Zafar M, Thomas R, Kotulska K, Jespers E, Dibué M, Kwan P
BMJ Neurol Open 2021;3:e000218.
https://doi.org/10.1136/bmj no-2021-000218

Recently (December, 2021), Dr. Sen et al. published a scientific paper describing the justification and study design, including potential subanalysis, of their ongoing, global, and #prospective #registry study (CORE-VNS). The study examines the long-term effectiveness and safety of vagus nerve stimulation (#VNS) in patients with drug-resistant epilepsy (#DRE).

As of June 2021, the registry has enrolled 823 participants from 15 different countries and 61 centers. All patients with DRE undergoing their first VNS implantation, or patients being reimplanted, are eligible for participation. Baseline characteristics are measured before and after VNS implantation (follow-up duration: 36-60 months). The endpoints (including seizure outcomes, non-seizure outcomes, and the use of various VNS Therapy features) of this study are listed in Table 1. Potential stratifications for subanalysis include seizure type, epilepsy etiology, and time to implantation.

This registry aims to establish one of the largest real-world clinical databases for a comprehensive understanding of the long-term effects of VNS Therapy for DRE.