Clinical trial NCT05720819: Biofeedback-VR for Treatment of Chronic Migraine
Official title: Utility of a Novel, Combined Biofeedback-Virtual Reality Device as Adjunctive Treatment for Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine
Behavioral Treatment
Biofeedback
Virtual Reality
Medication Overuse Headache
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2023-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean headache days per month
timeFrame: Baseline compared with week 12
Secondary outcomes:
measure: Frequency of total acute analgesic medication uses per month
timeFrame: Baseline compared with week 12
measure: Depression score (Patient Health Questionnaire-8)
timeFrame: Baseline compared with week 12
measure: Migraine associated disability score (Migraine Disability Assessment)
timeFrame: Baseline compared with week 12
measure: Stress score (Perceived Stress Scale)
timeFrame: Baseline compared with week 12
measure: Catastrophizing score (Concerns about Pain scale)
timeFrame: Baseline compared with week 12
Other outcomes:
measure: Heart rate variability score
timeFrame: Baseline compared with week 12
measure: Qualitative impressions of the intervention
timeFrame: Baseline compared with week 12
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ami Z Cuneo, MD
role: PRINCIPAL_INVESTIGATOR
References: