Compatibility of standard vagus nerve stimulation and investigational microburst vagus nerve stimulation therapy with functional magnetic resonance imaging

ABSTRACT

Vagus nerve stimulation devices are conditionally approved in MRI with stimulation turned off and the requirement to modify the stimulation settings may be a barrier to scanning in some radiology practices. There is increasing interest in studying the effects of stimulation during MRI/fMRI. This study evaluated the safety of standard and investigational microburst vagus nerve stimulation therapies during MRI/fMRI. A prospective, multi-center study was conducted in patients with an investigational vagus nerve stimulation device that delivered either standard or investigational microburst vagus nerve stimulation. Thirty participants underwent sequential MRI and fMRI scans encompassing 188 total hours of scan time (62.7 hours with standard vagus nerve stimulation and 125.3 with investigational microburst vagus nerve stimulation). No adverse events were reported with active stimulation during MRI or during 12 months of follow-up. Our results support the safety and standard and investigational microburst vagus nerve stimulation therapy during MRI and fMRI scans.

ABBREVIATIONS: VNS = vagus nerve stimulation; µVNS = microburst VNS; DRE = drug-resistant epilepsy; U.S. = United States; FOS = focal onset seizures; PGTC = primary generalized tonic-clonic seizures; IDE = investigational device exemption; SD = standard deviation; EEG = electroencephalogram.