Virtual Reality Clinical Trial
Official title:
Utility of a Novel, Combined Biofeedback-Virtual Reality Device as Adjunctive Treatment for Chronic Migraine
Verified date | February 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 1, 2022 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Heart rate variability score | Measurement of average heart rate variability in the experimental group alone. | Baseline compared with week 12 | |
Other | 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. | Baseline compared with week 12 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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