Biofeedback-VR for Treatment of Chronic Migraine

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Combined biofeedback-virtual reality device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (Biofeedback-VR intervention plus standard clinical care)<br>This arm includes individuals with chronic migraine receiving the home-based biofeedback-VR intervention plus standard medical care as treatment for chronic migraine | Device: Combined biofeedback-virtual reality device<br>* 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.<br>|
| No Intervention: Control Group (standard clinical care alone)<br>This arm, a wait-list control group, includes individuals with chronic migraine receiving standard medical care alone as treatment for chronic migraine. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean headache days per month | Mean headache days per month in the experimental group, as compared with mean headache days per month in the control group. | Baseline compared with week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of total acute analgesic medication uses per month | Frequency of total acute analgesic medication uses per month in the experimental group, as compared with total acute analgesic medication uses per month in the control group. | Baseline compared with week 12 | 
| Depression score (Patient Health Questionnaire-8) | Depression score in the experimental group, as compared with depression score in the control group. The lowest attainable score is 0 and the highest attainable score is 24. A score of 0-4 is no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-24 severe depression. | Baseline compared with week 12 | 
| Migraine associated disability score (Migraine Disability Assessment) | Migraine associated disability score in the experimental group, as compared with the migraine associated disability score in the control group. Minimum score is 0, maximum score is indefinite. Score of 0-5 is defined as minimal disability, 6-10 as mild disability, 11-20 as moderate disability, and score of at least 21 is severe disability. | Baseline compared with week 12 | 
| Stress score (Perceived Stress Scale) | Stress score in the experimental group, as compared with the stress score in the control group. Minimum score is 0, maximum score is 40. Score 0-13 is low stress, 14-26 reflects moderate stress, 27-40 reflects high stress. | Baseline compared with week 12 | 
| Catastrophizing score (Concerns about Pain scale) | Catastrophizing score in the experimental group, as compared with the catastrophizing score in the control group. The minimum score is 6 and the maximum score is 30. Scores are converted into a T score metric. A higher score suggests increased concern about pain. | Baseline compared with week 12 |