Transnasal cooling device shows promise for migraine pain

Key takeaways:

• Pain relief at 2 hours was 70.6% in the treatment group vs. 56% for sham.
• 10 L per minute was the most effective dose, with 47.1% of participants having pain freedom at 2 hours.

SAN DIEGO — Significantly more patients with acute migraine who received a 10 L per minute dose of a transnasal cooling device had pain freedom at 2 hours vs. those who received sham, according to research presented at the AAN Annual Meeting.

“There is a critical need for alternative, acute migraine treatments, as many patients experience inadequate pain relief, intolerable side effects or contraindications to existing therapies,” MaryAnn Mays, MD, a neurologist in the Center for Neuro-Restoration at the Cleveland Clinic, said during AAN’s Top Science Press Conference. “Neuromodulation is an expanding field in headache medicine and multiple FDA-approved devices are available for migraine treatment.”

Mays and colleagues evaluated the safety, efficacy and tolerability of the noninvasive, at-home administered Mi-Helper neuromodulation device to treat acute migraine with or without aura.

Their randomized, prospective, double-blinded, dose-finding, sham-controlled clinical trial enrolled 172 individuals aged 18 to 65 years with acute migraine. Among them, 128 were randomly assigned to treat a single migraine attack with Mi-Helper or sham for 15 minutes within 1 hour of headache onset.

The final efficacy analysis included 74 individuals. Among them, 14 were assigned to 4 L per minute (4LPM) of Mi-Helper, 18 were assigned to 6LPM of Mi-Helper, 17 were assigned to 10LPM of Mi-Helper and 25 were assigned to sham.

The primary study endpoints were pain relief and pain freedom 2 hours post dose. Additional endpoints included sustained pain relief and freedom up to 24 hours post dose, as well as tolerability measurements.

Mays and colleagues reported that 10LPM was “the best active dose” of Mi-Helper.

There was a significantly higher proportion of patients in the 10LPM group who experienced pain freedom at 2 hours compared with sham (47.1% vs. 16%.)

When looking at pain relief alone at 2 hours, there was a higher proportion of patients in the 10LPM group (70.6%) compared with sham (56%), but the difference was not statistically significant. Similarly, the percentage of those experiencing sustained pain freedom without resorting to rescue medication was higher for those given a 10LPM dose vs. sham (41.2% vs. 16%), but the finding was not statistically significant.

The researchers further noted that Mi-Helper was well tolerated, with no enrollees discontinuing treatment and no serious adverse events recorded.

“With 37 million Americans affected by migraines, the condition ranks as the second-leading cause of disability globally,” Mays said. “Clearly there is a need for effective, safe and drug-free treatments. Mi-Helper represents an innovative step in neuromodulation.”