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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (Biofeedback-VR intervention plus standard clinical care) | Experimental | This arm includes individuals with chronic migraine receiving the home-based biofeedback-VR intervention plus standard medical care as treatment for chronic migraine |
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| Control Group (standard clinical care alone) | No Intervention | This arm, a wait-list control group, includes individuals with chronic migraine receiving standard medical care alone as treatment for chronic migraine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined biofeedback-virtual reality device | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability score | Measurement of average heart rate variability in the experimental group alone. | Baseline compared with week 12 |
| Qualitative impressions of the intervention | Qualitative impressions of experience with the biofeedback-virtual reality treatment for the experimental group alone. This is measured via questionnaires. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ami Z Cuneo, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98105 | United States |
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| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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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 |
| Baseline compared with week 12 |