Noninvasive Vagus Nerve Stimulation Studies More Consistently Adhere to IHS Guidelines

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PHILADELPHIA — Adherence to International Headache Society (IHS) guidelines is most consistent in migraine and cluster headache studies focused on noninvasive vagus nerve stimulation, according to research presented at the American Headache Society 61st Annual Scientific Meeting, held July 11 to 14, 2019, in Philadelphia, Pennsylvania.

This systematic review sourced 71 studies from Cochrane Library,, PubMed, and the World Health Organization’s International Clinical Trials Registry Platform. Studies included incorporated noninvasive neuromodulation devices to treat cluster headache or migraine, and were published between January 1990 and January 2018. Studies utilizing observational or diagnostic-only designs, healthy individuals or those with comorbidities, and invasive therapies were not included. Heterogeneity of study design and endpoints for all studies were established via systematic review and evaluation. Adherence to IHS guidelines among the studies was assessed by two independent reviewers.

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A total of 16 noninvasive neuromodulation devices were investigated among the chosen studies. Of these, 3 had regulatory clearance: noninvasive vagus nerve stimulation, single-pulse transcranial magnetic stimulation, and external trigeminal nerve stimulation. IHS guideline adherence was observed in the 11 studies utilizing noninvasive vagus nerve stimulation, 1 out of 3 single-pulse transcranial magnetic stimulation studies, and 2 out of 6 external trigeminal nerve stimulation studies.

The investigators concluded that “[noninvasive vagus nerve stimulation] studies demonstrated the most consistent adherence to IHS recommendations. Similar rigor should be used for designs of future studies of all noninvasive devices to facilitate comparisons across devices.” They go on to state that, “[r]ecommendations for evaluating noninvasive neuromodulation therapies for the treatment of migraine and cluster headache will soon be available, but adherence to current recommendations for evaluating pharmacologic treatments offers a key point of comparison for investigators and clinicians in the interim.”


Reuter U, McClure C, Liebler E, Pozo-Rosich P. Systematic review of clinical studies evaluating non-invasive neuromodulation for migraine and cluster headache. Poster presented at: American Headache Society 61st Annual Scientific Meeting; July 11-14, 2019; Philadelphia, PA. Submission 630655.