Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-09-09
2022-03-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention Group (Biofeedback-VR intervention plus standard clinical care)
This arm includes individuals with chronic migraine receiving the home-based biofeedback-VR intervention plus standard medical care as treatment for chronic migraine
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.
Control Group (standard clinical care alone)
This arm, a wait-list control group, includes individuals with chronic migraine receiving standard medical care alone as treatment for chronic migraine.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
University of Washington
OTHER
Responsible Party
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Ami Cuneo
Acting Assistant Professor, School of Medicine
Principal Investigators
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Ami Z Cuneo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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STUDY00010685
Identifier Type: -
Identifier Source: org_study_id
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