To determine if frequent use of a combined biofeedback-virtual reality device improves headache-related outcomes in chronic migraine.
In this randomized, controlled pilot study, 50 adults with chronic migraine were 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 was reduction in mean monthly headache days between groups at 12 weeks. Secondary outcomes included mean change in acute analgesic use frequency, depression, migraine-related disability, stress, insomnia, and catastrophizing between groups at 12 weeks. Tertiary outcomes included change in heart rate variability and device-related user experience measures.
A statistically significant reduction in mean monthly headache days between groups was not demonstrated at 12 weeks. However, statistically significant decreases in mean frequency of total acute analgesic use per month (65% decrease in the experimental group versus 35% in the control group, P<0.01) and depression score (35% decrease in the experimental group versus 0.5% increase in the control group; P<0.05) were shown at 12 weeks. At study completion, more than 50% of participants reported device satisfaction on a 5-level Likert scale.
Frequent use of a portable biofeedback-virtual reality device was associated with decreases in frequency of acute analgesic use and in depression in individuals with chronic migraine. This platform holds promise as an add-on treatment for chronic migraine, especially for individuals aiming to decrease acute analgesic use or interested in non-medication approaches.

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