NCT05720819

Biofeedback-VR for Treatment of Chronic Migraine

Utility of a Novel, Combined Biofeedback-Virtual Reality Device as Adjunctive Treatment for Chronic Migraine

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Migraine
• Behavioral Treatment
• Biofeedback
• Virtual Reality
• Medication Overuse Headache

Interventions

Type	Name	Description
DEVICE	Combined biofeedback-virtual reality device	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.

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-04-01
• Completion: 2022-03-01
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

1 site across 1 country: United States