Biofeedback-VR for Treatment of Chronic Migraine
Condition: Chronic Migraine; Behavioral Treatment; Biofeedback; Virtual Reality; Medication Overuse Headache
MeSH terms: Migraine Disorders; Headache Disorders, Secondary; Headache
Study type: Interventional

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.
    

Detailed description: 
      Chronic migraine (CM) is a debilitating neurologic condition affecting 1-2% of the
      population. By definition, individuals with CM experience at least 15 headache days per month
      (including at least 8 migraine days) for more than 3 months. In addition to frequent,
      debilitating headaches, CM is associated with increased rates of headache-related disability,
      psychiatric comorbidity, pain catastrophizing, insomnia, risk of medication overuse headache,
      and healthcare resource utilization.

      Established treatments for migraine include medications, vitamin and herbal supplements,
      neuromodulation, and behavioral treatment strategies. Our 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.
    

Intervention name(s): Combined biofeedback-virtual reality device
Intervention type(s): Device
Intervention description(s): The study's biofeedback-VR device was developed in collaboration with students and faculty at the University of Washington Global Innovation Exchange program. The system included an Oculus Go mobile VR headset (wireless, portable, head-mounted display, with screen providing a 101° field of view with 2560 x 1440 resolution at a 60-72 Hz frame rate; Oculus VR, LLC, Menlo Park, CA/USA) and with built-in speaker, in addition to a Polar H10 heart rate monitor (electrocardiogram, or ECG, to measure heart rate; Polar Electro Inc., Bethpage, NY/USA), with customized software programmed for the study using the Unity3D game engine (Unity Technologies, Bellevue, WA/USA). Individuals in the experimental arm are asked to use this device for 10 minutes daily, on at least 3 days per week.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This study is a randomized, pilot study comparing the intervention of combined biofeedback-VR plus standard medical care as treatment for chronic migraine versus a wait-list control group receiving standard medical care alone as treatment for chronic migraine.
Masking: None (Open Label)
Primary purpose: Treatment