Biofeedback-VR for Treatment of Chronic Migraine

Conditions: Chronic Migraine, Behavioral Treatment, Biofeedback, Virtual Reality, Medication Overuse Headache

Summary

Migraine is a common, debilitating neurologic condition affecting more than 900 million individuals worldwide. Established treatments for migraine include medications, vitamin and herbal supplements, neuromodulation, and behavioral treatment strategies. This study aims to determine whether a novel, home-based behavioral approach, combined biofeedback-virtual reality therapy, can improve self-reported migraine-related outcomes in individuals living with chronic migraine.In this randomized, controlled pilot study, 50 adults with chronic migraine are randomized to the experimental group (frequent use of a heart rate variability biofeedback-virtual reality device plus standard medical care; n=25) or wait-list control group (standard medical care alone; n=25). The primary outcome is reduction in mean monthly headache days between groups at 12 weeks. Secondary outcomes include mean change in acute analgesic use frequency, depression, migraine-related disability, stress, insomnia, and catastrophizing between groups at 12 weeks. Tertiary outcomes include change in heart rate variability and device-related user experience measures.

Eligibility Criteria

Inclusion Criteria:Diagnosis of International Classification of Headache Disorders (ICDH-3 beta) criteria for chronic migraineIndividuals having experienced least 15 headache days per month (including at least 8 migraine days per month) in the preceding 3 monthsAbility to speak English or SpanishExclusion Criteria:Individuals with cognitive impairment, severe psychiatric comorbidities (including active suicidal or homicidal ideation and/or psychosis), hearing/seeing difficulties, epileptic or non-epileptic seizures, and prisoners.

Source: ClinicalTrials.gov (NCT05720819). StuddyBuddy aggregates publicly available trial information.