Biofeedback-VR for Treatment of Chronic Migraine

NCT05720819 | Completed

• 1 other identifier: STUDY00010685
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Migraine; Behavioral Treatment; Biofeedback; Virtual Reality; Medication Overuse Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Frequency of total acute analgesic medication uses per month

  Baseline compared with week 12

• Depression score (Patient Health Questionnaire-8)

  Baseline compared with week 12

• Migraine associated disability score (Migraine Disability Assessment)

  Baseline compared with week 12

• Stress score (Perceived Stress Scale)

  Baseline compared with week 12

• Catastrophizing score (Concerns about Pain scale)

  Baseline compared with week 12

Other Outcomes (2)

• Heart rate variability score

  Baseline compared with week 12

• Qualitative impressions of the intervention

  Baseline compared with week 12

Study Arms (2)

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

Device: Combined biofeedback-virtual reality device

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.

Interventions

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.

Intervention Group (Biofeedback-VR intervention plus standard clinical care)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead
• University of California, San Francisco: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Headache Disorders, Secondary

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ami Z Cuneo, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor, School of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: February 9, 2023
• Study Start: September 9, 2020
• Primary Completion: April 1, 2021
• Study Completion: March 1, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)