Compatibility of Standard Vagus Nerve Stimulation and Investigational Microburst Vagus Nerve Stimulation Therapy with fMRI

Abstract

Vagus nerve stimulation devices are conditionally approved for MR imaging 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 MR imaging/fMRI. This study evaluated the safety of standard and investigational microburst vagus nerve stimulation therapies during MR imaging/fMRI. A prospective, multicenter 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 MR imaging and fMRI scans, encompassing 188 total hours of scan time (62.7 hours with standard vagus nerve stimulation and 125.3 hours with investigational microburst vagus nerve stimulation). No adverse events were reported with active stimulation during MR imaging or during 12 months of follow-up. Our results support the safety of standard and investigational microburst vagus nerve stimulation therapy during MR imaging and fMRI scans.

FIG 1.

Implanted VNS device. The pulse generator is implanted in the left chest, and the lead is connected to the left vagus nerve in the neck. VNS pulses are delivered to the brain via the vagus nerve. Adapted with permission from Verner et al.

FIG 2.

Exclusion zone and permissible area during MR imaging for the head and extremity using local transmit/receive head or extremity coils. RF indicates radiofrequency.

FIG 3.

Exclusion zone and permissible area during MR imaging for the body using the body-transmit coil and the local receive-only coil.

FIG 4.

Microburst participant accountability showing the initial enrollment through study completion plus study attrition.