Virtual Reality Mindfulness for Migraine

(MIRAGE Trial)

Not yet recruiting at 2 trial locations
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Overseen Byasimina lazaridou, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
Must be taking: CGRP mAb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The aim of this clinical trial is to learn if people with migraine can learn a type of biobehavioral therapy called Acceptance and Commitment Therapy (ACT) by using a virtual reality headset. Researchers are studying if this type of mindfulness therapy helps to decrease migraine-related disability. Participants will be randomized to treatment as usual or active virtual reality groups for four weeks. Everyone will keep symptom diaries, complete surveys, attend two clinic visits, and have two blood draws.

Who Is on the Research Team?

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carolyn bernstein, MD

Principal Investigator

BWH

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who have been diagnosed with episodic migraine (4-10 migraine days per month), are on a stable dose of certain migraine medication, not taking other preventive meds, not pregnant or breastfeeding, and able to use a VR headset. Participants must speak English and have no major psychiatric illness.

Inclusion Criteria

* Not pregnant, breastfeeding, or planning to become pregnant within study timeframe
* No history of significant psychiatric illness
* Willing to comply with study procedures
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants are randomized to treatment as usual or active virtual reality groups for four weeks. Active participants use a VR device at home and engage in various experiences.

4 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in inflammatory biomarkers and migraine-related anxiety and depression.

12 weeks
Blood tests at baseline and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ACT therapy delivered by REACT NeuroVR headset

Trial Overview

The study tests if mindfulness therapy called Acceptance and Commitment Therapy (ACT) can be taught using a virtual reality headset to help people with migraines. Participants are randomly assigned to either usual care or the VR-ACT group for four weeks.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Treatment as usualActive Control1 Intervention
Group II: Active TreatmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+