AAN 2025 | The efficacy and safety of the Mi-Helper transnasal cooling device for the treatment of migraine

Yes, I was very excited at this year’s AAN to present on the Mi-Helper device, which is a very unique transnasal cooling device, neuromodulation, which targets the sphenopalatine ganglion, which is a small nerve bundle in the upper airway, which we know is linked to the trigeminal nerve involved in migraine pathophysiology and often contributes to some of the symptomatology of migraine. And for a long time, we’ve always known that the sphenopalatine ganglion, or SPG, is a potential target for interventions for migraine. So Mi-Helper is a thermal neuromodulation device that uses dry air that passes over the nasal mucosa and extracts energy. And by doing that, produces local cooling of the nasal cavity, which then inhibits the SPG, or sphenopalatine ganglion to relieve migraine without the use of medications. So we were pleased with the results of the Mi-Helper study, which showed that pain freedom at two hours was higher in the 10 liters per minute group, with 47% of patients reporting pain freedom at two hours compared to 16% of the sham group. In regards to pain relief, there was a higher percentage of patients in the 10 liters per minute group reporting pain relief in two hours of 71% compared to 56% of placebo, although this was not significantly different. What’s important to know also as a secondary endpoint is that there was no evidence of pain recurrence at 24 hours or use of rescue medication for 41% of the patients in the 10 liters per minute group. So this really shows that the Mi-Helper is a safe, non-invasive neuromodulation device that can be used by patients both independently as a self-alone treatment or in conjunction with their other therapies. It’s quick, effective, and the tolerability was very good with very few side effects of rhinorrhea or nasal congestion.

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