Home-based Biofeedback for the Prevention of Migraine

Prior treatment

• 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) monotherapy of migraine preventive medication · Subjects who have previously attempted three or more prophylactic pharmacological treatments in adequate doses, without significant clinical effect.
• Alcohol overuse or illicit drug use.

Other illness

• Subjects with secondary headache conditions.

Other

• More than 14 days of headache (all types) per 28-day period.
• Subjects diagnosed with trigeminal autonomic cephalalgias and neuralgias.
• Subject with pathologies that inhibit use of the device according to the instructions for use (e.g., blindness, deafness).
• Subjects taking opioids (\>3 days per month) or barbiturates at the time of screening.
• Subject participates in another clinical investigation or has participated in CER-MIG-1.
• Subject who is unlikely to follow Clinical Investigation Plan or where treatment seems futile in the opinion of the Investigator or have demonstrated an inability to sufficiently adhere to headache diary entries (\<70%).

• 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.