Transcutaneous vagus nerve stimulation as add-on therapy versus pharmacotherapy alone (TRAVAST): study protocol for a prospective, randomised, triple-blind, controlled, multicentre trial
Abstract
Introduction: Despite optimised antiseizure medication, pharmacoresistant epilepsy still affects a substantial proportion of adult patients, especially when epilepsy surgery is not possible or is rejected. Transcutaneous vagus nerve stimulation (t-VNS) is a non-invasive neuromodulatory approach for which the evidence from randomised studies to date does not allow for a reliable assessment of its benefits due to small case numbers and methodological limitations. Transcutaneous vagus nerve stimulation as add-on therapy versus pharmacotherapy alone (TRAVAST) is a prospective, multicentre, randomised, triple-blind, controlled trial to investigate whether t-VNS as an add-on to established pharmacotherapy improves seizure-related and patient-relevant outcomes in adults with pharmacoresistant epilepsy.
Methods and analysis: A total of 164 adults (aged 18-65) with pharmacoresistant epilepsy and clinically manifest seizures who are not eligible for or refuse (further) resective epilepsy surgery will be enrolled at 15 sites. Patients are assigned 1:1 to active t-VNS or sham stimulation in addition to stable antiseizure medication for 12 months. t-VNS is performed using a non-implanted stimulator with an ear electrode as a daily self-administered therapy in the home environment. The primary outcome is the proportion of patients with at least 50% reduction in mean seizure frequency after 52±2 weeks compared with a 4-week baseline period, documented in a standardised epilepsy diary.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 164 participants or records.
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