A Prospective, Double-blind, Sham-controlled, Randomized Clinical Trial to Assess the Safety and Efficacy of the Mi-Helper Device for Acute Treatment of Migraine in an At Home Setting.
This is a prospective, double-blind, sham-controlled, randomized, decentralized trial. This study aims to assess the safety and efficacy of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting. Adults aged 18 years to 70 years old with a diagnosis of migraine (with or without aura) for at least one year will be recruited for this study.
• Age of 18 to 70 years, inclusive, of either sex at birth.
• Lives in the contiguous United States.
• Self-reported to be able to read and understand English sufficiently to provide electronic Informed Consent.
• Diagnosis of migraine with or without aura for at least 1 year.
• Individual experiences 2 to 8 migraine attacks per month documented via migraine eDiary during screening.
• Migraine onset before 50 years of age, self-reported during screening.
• Migraine preventive medication unchanged for 4 weeks prior to study enrollment.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Individuals that own a functioning smartphone device, internet connection (Wi-Fi or data plan) and are willing to download the study app.