Non-invasive neuromodulation for migraine and cluster headache: a systematic review of clinical trials

What is it about?

We conducted a systematic review of the scientific rigor of clinical studies of non-invasive neuromodulation devices for the treatment of migraine and cluster headache. This review highlights the lack of study design consistencies, which may be the result of the absence of institutional guidelines for evaluating these devices. We compared the clinical trials of neuromodulation devices against the recommendations for drugs, which are the only currently available guidelines in migraine and cluster headache. This review will help inform clinicians of the lack of consistency in studies of non-invasive neuromodulation devices and stress the need for more evidence-based standards specific to these devices. The lack of uniformity in these studies precludes a formal meta-analysis, but our critical analysis of study designs may influence the development of guidelines for evaluating non- invasive neuromodulation devices in the treatment of migraine and cluster headache. Dr. Uwe Reuter: “Although higher-quality neuromodulation trials are being carried out, the majority of the trials we reviewed failed to meet the standards for drug trials. This review will serve to underscore the importance of developing universal guidelines as a means for strengthening the scientific rigor of non-invasive neuromodulation device trials – and as a consequence, strengthening the quality and reliability of the clinical data they yield. Until such guidelines become available, neuromodulation studies should strive to meet the recommendations for drug studies so that clinicians have the confidence to prescribe these new devices to their patients.”

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