Trial results for a study investigating the Mi-Helper transnasal cooling device for Migraine were posted on ClinicalTrials.gov on 2026-02-10. The study, which enrolled 156 participants, aimed to assess the device's safety and efficacy for acute migraine treatment.
Background
Migraine is a debilitating neurological condition characterized by severe headaches, often accompanied by symptoms such as throbbing pain, nausea, vomiting, and extreme sensitivity to light and sound. These attacks can significantly impair daily activities and quality of life. Effective acute treatments are crucial for managing migraine episodes, providing rapid relief from pain and associated symptoms. Non-pharmacological interventions, such as cooling devices, represent an area of ongoing research for patients seeking alternatives or adjuncts to traditional medications.
Trial design
This completed study, titled "Cooling to Alleviate Migraine #3," was a prospective, double-blind, sham-controlled, randomized, decentralized trial. It enrolled 156 adult participants, aged 18 to 70 years, diagnosed with Migraine With or Without Aura, Migraine, or Migraine Headache for at least one year. The trial assessed the safety and efficacy of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at-home setting. Participants were randomized to either Group I (Active Treatment) or Group II (Sham).
Key results
The trial results included several key measurements comparing the active treatment group (Group I) to the sham group (Group II):
- For "Pain Freedom at 2 Hours Post Treatment," 15 participants in Group I achieved this, compared to 14 participants in Group II.
- "Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment" was achieved by 21 participants in Group I and 26 participants in Group II.
- "Sustained Pain Freedom at 24 Hours Post Treatment" was achieved by 8 participants in Group I and 11 participants in Group II.
- For "Pain Relief at 2 Hours Post Treatment," 35 participants in Group I experienced relief, compared to 38 participants in Group II.
- Regarding "Participants' Global Impression of Acute Treatment Effect," one measurement reported 20 participants in Group I and 32 in Group II, while another reported 41 participants in Group I and 32 in Group II.
Key analyses using the Chi-squared method also provided insights, though specific outcome titles for these analyses were not provided:
- Odds Ratios (OR) ranged from 0.7 to 1.2 (95.0% CIs varied), with p-values of 0.7194, 0.5214, 0.5002, and 0.8202 for four analyses.
- One analysis reported an Odds Ratio, log, of 0.5 (95.0% CI: 0.2-1.0) with a p-value of 0.0471.
What this means
The posted results from the "Cooling to Alleviate Migraine #3" trial indicate that the Mi-Helper transnasal cooling device did not demonstrate a clear superiority over sham treatment across several key efficacy endpoints for acute migraine relief. For instance, pain freedom at 2 hours was similar between the active (15 participants) and sham (14 participants) groups. Similarly, freedom from the most bothersome symptom and sustained pain freedom at 24 hours showed comparable or slightly better outcomes in the sham group. While one analysis reported a p-value of 0.0471, the specific outcome to which this applies is not detailed in the provided data. Overall, based on the available measurements and analyses, the trial's findings do not strongly support the efficacy of the Mi-Helper transnasal cooling device as a significantly more effective acute migraine treatment compared to a sham device.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT06874361, titled "Cooling to Alleviate Migraine #3", were posted on 2026-02-10 on clinicaltrials.gov.