SAFETY AND USABILITY FACTORS IN DEVELOPMENT OF A NOVEL, AUTOMATED TREATMENT DEVICE FOR ACUTE MIGRAINE

摘要

A recent discovery revealed a therapeutic effect of external ear insufflation in the treatment of acute migraine headache. This finding led to the development of a treatment method and device for its delivery to human subjects. The challenges associated with developing an automated device, designed for unsupervised public use, included mitigation of risks associated with potential bodily harm as well as promoting the optimal user experience in terms of comfort and ease of use. The primary risk associated with this form of treatment device is the potential for compromise of the tympanic membrane due to accidental over-pressure at the external ear canal. User comfort in migraineurs poses challenges primarily driven by the fact that many report their primary headache pain is frequently associated with heightened sensitivity to sensory stimuli, such as light (photophobia), sound (phonophobia) and touch (allodynia). We took a number of measures to mitigate safety risks, promote consistency of the therapeutic effect, and improve user comfort. When the proprietary, automated, variable pulse insufflator device was used in a clinical setting with 30 subjects, all of whom were reporting for treatment while suffering from acute migraine, it brought about a 67% complete pain resolution rate at the 2-hour, post-treatment end-point. Users reported a consistently favorable and very comfortable experience with the device and treatment method. Overall, results appeared to demonstrate a promising, novel treatment option for acute migraine with appealing safety profile as an alternative or adjunct to drug treatment.