Utility of a Novel, Combined Biofeedback-Virtual Reality Device as Adjunctive Treatment for Chronic Migraine
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Migraine
- Sponsor
- University of Washington
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Mean headache days per month
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Ami Cuneo
Acting Assistant Professor, School of Medicine
University of Washington
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of International Classification of Headache Disorders (ICDH-3 beta) criteria for chronic migraine
- •Individuals having experienced least 15 headache days per month (including at least 8 migraine days per month) in the preceding 3 months
- •Ability to speak English or Spanish
Exclusion 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.
Outcomes
Primary Outcomes
Mean headache days per month
Time Frame: Baseline compared with week 12
Mean headache days per month in the experimental group, as compared with mean headache days per month in the control group.
Secondary Outcomes
- Frequency of total acute analgesic medication uses per month(Baseline compared with week 12)
- Catastrophizing score (Concerns about Pain scale)(Baseline compared with week 12)
- Depression score (Patient Health Questionnaire-8)(Baseline compared with week 12)
- Stress score (Perceived Stress Scale)(Baseline compared with week 12)
- Migraine associated disability score (Migraine Disability Assessment)(Baseline compared with week 12)