An investigational device that delivered conditioned room air intranasally treated acute migraine attacks without drugs, a randomized sham-controlled study showed.
Compared with sham, transnasal dry air flow at 10 L per minute using the Mi-Helper device was effective in treating acute migraine, said MaryAnn Mays, MD, of the Cleveland Clinic, in a late-breaking presentation at the American Academy of Neurology (AAN) annual meeting.
Mi-Helper targets the sphenopalatine ganglion (SPG), a nerve bundle behind the nasal passages involved in migraine pathophysiology.
"Using dry room-temperature air, Mi-Helper elicits local cooling of the nasal cavity, which calms or inhibits the SPG, relieving migraine pain and the need for medication," Mays said.
Mi-Helper is the first noninvasive neuromodulation of the SPG to demonstrate efficacy, she pointed out. It consists of a tabletop device, tubeset, and drying cartridge. Air is drawn into the device, dried in the cartridge, and delivered to the patient through a single-use tubeset.
Patients perceive the air as "cool, but not uncomfortable," Mays said. "Many patients feel it's very comfortable and soothing."
Earlier research suggested that modulating the SPG through transnasal evaporative cooling provided relief from migraine attacks, she noted.
The Mi-Helper trial was decentralized; participants self-administered the device in their homes. The study included 172 adults ages 18 to 65 who had episodic migraine. Overall, 128 participants were treated with Mi-Helper.
A subset of 74 participants were included in the final efficacy analysis. Participants were randomized to one of three doses -- 4, 6, or 10 L per minute -- or sham treatment. They treated a single migraine attack for 15 minutes within 1 hour of migraine onset.
The efficacy analysis included 14 people in the group receiving 4 L per minute; 18 people in the 6-L group, 17 people in the 10-L group, and 25 people in the sham group. Mean ages ranged from 38 to 44 years across groups, and more than 75% of the study sample were women. Most participants were white.
The trial aimed to determine the most effective dose while assessing efficacy, safety, and tolerability. Primary endpoints were pain relief and pain freedom at 2 hours. Secondary endpoints included sustained pain freedom up to 24 hours.
In the group receiving 10 L per minute, a higher percentage of participants were pain-free at 2 hours compared with the sham group (47.1% vs 16%, P=0.029). Pain relief at 2 hours was higher in the 10-L group compared with sham, but this was not significant (70.6% vs 56%, P=0.339).
The percentage of participants who had sustained pain freedom from 2 to 24 hours was higher in the 10-L group compared with sham, but this trend also did not reach statistical significance (41.2% vs 16%, P=0.069).
"The device was well tolerated and there were no treatment discontinuations or serious safety events," Mays said. All device-related adverse events were graded mild or moderate. At the 10-L dose, the most common adverse events were rhinorrhea, nasal irritation, ear pressure, and congestion.
Recruitment for a decentralized pivotal trial to further assess Mi-Helper began in March, Mays noted.
"There's a critical need for alternative acute migraine treatments as many patients experience inadequate pain relief, intolerable side effects, or contraindications to existing therapies," she said at the AAN's top science press conference.
"Neuromodulation is an expanding field in headache medicine, and multiple FDA-approved devices are available for migraine treatment," she added. "Mi-Helper offers a safe, effective, and accessible option used as a standalone treatment or with other existing therapies to help reduce the pain of migraine and decrease reliance on medications, including opioids."
Disclosures
This study was supported by Mi-Helper, Inc.
Mays reported being a paid medical advisor and part of the study monitoring committee for Cool Tech, LLC.
Primary Source
American Academy of Neurology
Source Reference: Mays M "Mi-Helper transnasal cooling for acute migraine treatment: a prospective, double-blind, randomized, sham-controlled, decentralized dosing study" AAN 2025.
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