External Trigeminal Neurostimulation In Patients with Chronic Migraine

Abstract

Aim: To assess the safety and efficacy of external trigeminal neurostimulation (e-TNS) as an add-on treatment in chronic migraine (CM) prophylaxis. Materials & methods: A prospective observational open-label study was conducted on CM patients observed at baseline and 3 months after starting daily sessions of 20 min with e-TNS (Cefaly^®). Results: A total of 24 volunteers affected by CM according to the ICHD-3 were included. At the 3 month follow-up, a >30% reduction of headache days was observed in four (16.5%) of 24 patients; a marginal headache improvement was observed in ten (42%) patients, with no or minor adverse effects (four of 24 patients). Conclusion: e-TNS may constitute a safe preventive treatment in CM, its limited efficacy is not statistically significant.

Plain language summary

Migraine is one of the most prevalent and disabling diseases in the world. In chronic migraine cases, patients have headache ≥15 days/month, of which at least eight are migraines, for >3 months and often develop a medication overuse headache because of the excessive intake of drugs. Preventive therapies include, among others, peripheral nerve stimulation. In our study, 24 patients affected by chronic migraine were asked to use a peripheral nerve stimulation device (Cefaly^®) for 20 min daily for 3 months. During this period, we evaluated the efficacy and safety of the treatment using specific headache diaries in which patients collect information about their symptoms and disability. Our results show a limited and not statistically significant reduction in headache days in a group of patients (‘responders’) without serious adverse reactions.

Tweetable abstract

An observational open-label study to assess external trigeminal neurostimulation as add-on treatment in chronic migraine concludes that external trigeminal neurostimulation may constitute a safe but not efficacious preventive treatment in chronic migraine patients.

Keywords::

• chronic migraine
• external trigeminal neurostimulation
• headache
• neuromodulation

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that informed consent has been obtained from the participants involved.