AUTHOR=Verner Ryan , Szaflarski Jerzy P. , Allendorfer Jane B. , Vonck Kristl , Giannicola Gaia , Microburst Study Group , McDermott Danielle , Brown Mesha Gay , Kaye Lesley , Macken Michael , Tatum William O. , Drees Cornelia , Benbadis Selim R. , Jaisani Zeenat , Zafar Muhammad , Vonck Kristl , O'Dwyer Rebecca , Newman Blake , Afra Pegah , Allendorfer Jane , Szaflarski Jerzy P. , Verner Ryan , Nichol Kathryn , Gordon Charles , Begnaud Jason , Keith Amy , Shamshiri Elhum , Fetzer Steffen , Ranuzzi Giovanni , Giannicola Gaia , Jiang Mei , Van Grunderbeek Wim , Bellinski Irena , Cunningham Elizabeth , Mertens Ann , Lynn Fiona , Aydemir Seyhmus TITLE=Modulation of the thalamus by microburst vagus nerve stimulation: a feasibility study protocol JOURNAL=Frontiers in Neurology VOLUME=14 YEAR=2023 URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1169161 DOI=10.3389/fneur.2023.1169161 ISSN=1664-2295 ABSTRACT=

Vagus nerve stimulation (VNS) was the first device-based therapy for epilepsy, having launched in 1994 in Europe and 1997 in the United States. Since then, significant advances in the understanding of the mechanism of action of VNS and the central neurocircuitry that VNS modulates have impacted how the therapy is practically implemented. However, there has been little change to VNS stimulation parameters since the late 1990s. Short bursts of high frequency stimulation have been of increasing interest to other neuromodulation targets e.g., the spine, and these high frequency bursts elicit unique effects in the central nervous system, especially when applied to the vagus nerve. In the current study, we describe a protocol design that is aimed to assess the impact of high frequency bursts of stimulation, called “Microburst VNS”, in subjects with refractory focal and generalized epilepsies treated with this novel stimulation pattern in addition to standard anti-seizure medications. This protocol also employed an investigational, fMRI-guided titration protocol that permits personalized dosing of Microburst VNS among the treated population depending on the thalamic blood-oxygen-level-dependent signal. The study was registered on clinicaltrials.gov (NCT03446664). The first subject was enrolled in 2018 and the final results are expected in 2023.