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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
156
The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.
SPRIM Pro
Indian Harbour Beach, Florida, United States
Pain Freedom at 2 Hours Post Treatment
Proportion of participants with a change in headache severity from mild/moderate/severe pain at baseline to no pain at 2 hours after treatment completion (if rescue medication was not used)
Time frame: 2 hours
Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post Treatment
Proportion of participants with a change from mild, moderate or severe symptom severity at baseline to none at 2 hours post treatment completion.
Time frame: 2 hours
Sustained Pain Freedom at 24 Hours Post Treatment
Proportion of participants with pain freedom with no administration of rescue medication and with no recurrence of a mild/moderate/severe headache
Time frame: 2-24 Hours
Pain Relief at 2 Hours Post Treatment
Proportion of participants with a change in headache severity from severe or moderate pain at baseline to mild or no pain at 2 hours post treatment completion, or from mild pain at baseline to no pain no pain at 2 hours after treatment completion (if rescue medication was not used)
Time frame: 2 hours
Participants' Global Impression of Acute Treatment Effect
Measured by the Patient Global Impression of Change (PGIC), on which participants use a 7-point scale, where 1=very much improved to 7=very much worse. Scores of 1 or 2 will be considered successes.
Time frame: 24 Hours
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