Virtual Reality Mindfulness for Migraine

(MIRAGE Trial)

Not yet recruiting at 2 trial locations
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al
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?

This trial explores whether a virtual reality headset can help reduce the impact of migraines by teaching mindfulness techniques. It specifically examines Acceptance and Commitment Therapy (ACT) delivered through the REACT NeuroVR headset to determine if it can decrease migraine-related disability. Participants will either maintain their usual treatment or engage in the VR mindfulness therapy for four weeks, tracking their symptoms throughout. The trial seeks individuals who experience 4-10 migraine days per month and are already on stable migraine prevention medication. As an unphased trial, it offers a unique opportunity to explore innovative migraine management techniques using cutting-edge technology.

Do I have to stop taking my current medications for the trial?

The trial requires that you are not taking any preventive medications other than a stable dose of CGRP mAb (a type of migraine medication) for three months before joining. If you are on other preventive medications, you may need to stop them.

What prior data suggests that this virtual reality mindfulness therapy is safe for migraine patients?

Research has shown that Acceptance and Commitment Therapy (ACT), when combined with a virtual reality headset, is generally easy for patients to manage. Studies have found that ACT can reduce disability in adults with migraines, offering a helpful approach without major safety concerns. A review of studies on acceptance-based treatments, including ACT, found them effective and safe for people with migraines. Additionally, virtual reality (VR) has successfully taught mindfulness, a key component of ACT, to migraine patients without major side effects.

Although limited safety data exists specifically for the REACT NeuroVR headset, VR has been used for mindfulness and ACT in other settings without significant safety issues. This suggests that the treatment is likely safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about using ACT therapy delivered through the REACT NeuroVR headset for migraines because it combines mindfulness with cutting-edge virtual reality technology. Unlike typical treatments, which often involve medications like CGRP monoclonal antibodies, this approach immerses patients in a virtual environment to enhance relaxation and stress management. This novel delivery method could offer a drug-free complement to traditional therapies, potentially reducing the frequency and intensity of migraine attacks in a way that is engaging and accessible.

What evidence suggests that this trial's treatments could be effective for migraine?

Research has shown that Acceptance and Commitment Therapy (ACT) can alleviate migraine symptoms and enhance overall life satisfaction. Studies have found that ACT improves emotional management and reduces the impact of migraines on daily life. In this trial, one group will engage in a four-week active virtual reality treatment using the REACT NeuroVR headset to deliver ACT, while continuing their CGRP mAb medication. Early results suggest that VR-based mindfulness therapy can effectively manage migraine issues. Combining mindfulness techniques with VR technology might provide a promising non-drug option for those suffering from migraines.12356

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
See 6 more

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+

Citations

Using Virtual Reality to Teach Mindfulness to People With ...

This study is designed to evaluate the clinical utility of REACT NeuroVR in patients with episodic migraine who are already receiving stable ...

Using Virtual Reality to Teach Mindfulness to People With ...

This study is designed to evaluate the clinical utility of REACT NeuroVR in patients with episodic migraine who are already receiving stable ...

Virtual Reality Mindfulness for Migraine (MIRAGE Trial)

... ACT therapy delivered by REACT NeuroVR headset will have tolerable side effects & efficacy for patients with Migraine, Migraine, Migraine ...

Effectiveness of Acceptance and Commitment Therapy on ...

The findings revealed that ACT consistently reduces symptom severity, improves emotional regulation, enhances life satisfaction, and increases psychological ...

Acceptance and Commitment Therapy to Improve Disability ...

The goal of this clinical trial is to learn if the behavioral treatment called Acceptance and Commitment Therapy (ACT) works to improve disability in adults ...

Developing interactive VR-based digital therapeutics for ...

This study proposes a practical framework for the digital transformation of Acceptance and Commitment Therapy (ACT) into an interactive virtual reality (VR) ...