Home-based Biofeedback for the Prevention of Migraine

Inclusion Criteria: * 18 years of age inclusive or older, at the time of signing the informed consent * Episodic migraines with or without aura diagnosed by a neurologist/physician per International Classification of Headache Disorders 3rd edition (ICHD-3). * History of at least 4 and up to 14 days of migraines per 28-day period in the 3 months prior to screening (as recalled by the subject). This frequency must be confirmed in the headache diary before randomization to treatment or wait-list control. * At least three months of experience with smartphone and access to an iOS or Android phone at home. * Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Onset of migraine before age 50 years. Exclusion Criteria: * More than 14 days of headache (all types) per 28-day period. * Subjects diagnosed with trigeminal autonomic cephalalgias and neuralgias. * Subjects with secondary headache conditions. * Subject with pathologies that inhibit use of the device according to the instructions for use (e.g., blindness, deafness). * Use of non-pharmacological preventive treatment (meditation, physical therapy, psychotherapy as a headache treatment, acupuncture, etc.), with the exception of stable treatment for other indications than migraine * Use of concurrent migraine preventive medication, with the exception of stable dose (≥3 months) mono…