Migraine DisordersMIRAGENCT07599228
Using Virtual Reality to Teach Mindfulness to People With Migraine
A study testing ACT therapy delivered by REACT NeuroVR headset in people with Migraine Disorders and Migraine With Aura, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Migraine Disorders, Migraine With Aura, Migraine Without Aura
- What is being tested?
- ACT therapy delivered by REACT NeuroVR headset
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2026to Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-80
- Diagnosed with episodic migraine and experience 4-10 migraine days/month
- On a stable dose of CGRP mAb for three months prior
- Satisfy 4 week run-in of 4-10 headaches/month
- Not taking other preventive medications
- Not pregnant, breastfeeding, or planning to become pregnant within study timeframe
Show all 10Show fewer
- Able and willing to use VR device
- No history of significant psychiatric illness
- Willing to comply with study procedures
- English-speaking
Who cannot join
- Medication overuse (>10 days/month)
- Vertigo/vestibular dysfunction
- Active psychiatric or neurological comorbidities
- Pregnancy, breastfeeding or planning pregnancy within study timeframe
- Significant visual/hearing/mobility impairment affecting VR use
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
asimina lazaridou, PhD contact
United States3 sites
Brigham and Womens Hospital
Boston, Massachusetts, 02155
Brigham and Women's Health Care Center
Chestnut Hill, Massachusetts, 02467
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
About this study
Official title: Migraine Intervention Using Reality-Assisted Guided Experience
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.
Read the detailed description
This study is designed to evaluate the clinical utility of REACT NeuroVR in patients with episodic migraine who are already receiving stable CGRP monoclonal antibody therapy. By combining pharmacologic advances with digitally delivered psychological support, we aim to assess whether this integrated approach can further reduce headache frequency, improve migraine-specific quality of life, and reduce anticipatory anxiety. Additionally, we will explore changes in inflammatory biomarkers to examine potential physiologic correlates of intervention-related improvement.
Ultimately, this study addresses a critical gap in migraine care: the integration of effective, accessible behavioral health strategies into the treatment paradigm for patients who continue to experience burdensome symptoms despite preventive therapy.
- Specific Aims and Objectives
Aim 1 (Pilot and Feasibility Study):
To evaluate the feasibility, acceptability, and usability of personalized Acceptance and Commitment Therapy (ACT) delivered via REACT NeuroVR. Focus groups with key stakeholders (patients, clinicians, and implementation experts) will be conducted to obtain feedback on intervention content, delivery, and outcome measures. Insights from this pilot phase will inform refinements to the intervention and study procedures for the subsequent full-scale clinical trial.
Aim 2 (Primary Efficacy Aim):
To determine whether personalized ACT therapy delivered via REACT NeuroVR reduces the number of monthly headache days in patients with episodic migraine compared to baseline.
Aim 3 (Psychological and Functional Outcomes):
To evaluate whether REACT NeuroVR improves migraine-specific quality of life and reduces anticipatory anxiety related to migraine events.
Aim 4 (Exploratory Biological and Sensory Aims):
To explore changes in inflammatory biomarkers.
Participants will:
Be randomized to treatment as usual or active VR participants Everyone who completes run-in will have a chance to try the VR device and have an additional screen.
Everyone will have a blood test at the beginning and the end of the study. Active participants will be loaned a VR device to take home for four weeks and will do the study activities as well as use a variety of experiences when they choose (such as beach visits, virtual ice baths and others) Participants will fill out surveys throughout the study.
Visit the clinic twice during the study Keep a diary of their symptoms and number of migraines
- Being tested
- ACT therapy delivered by REACT NeuroVR headset
- Keywords
- acceptance and commitment therapy (ACT), migraine, virtual reality, mindfulness, Calcitonin Gene-Related Peptide monoclonal antibody therapy
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT therapy delivered by REACT NeuroVR headsetBehavioural
This is ACT/mindfulness therapy delivered via a virtual reality headset.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication |
| Active Treatment | Active comparator | This group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication. Receives: Behavioral: ACT therapy delivered by REACT NeuroVR headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase one: Qualitative Interview of User Experience
Assessment of user experience captured using open ended questions, yes/no questions, and a 4-point scale ranging from "Very Poor" to "Very Good".
Measured: 2 weeks
Phase one: rate of participants using virtual reality for migraine-- qualitative data
Assessment of how often and how long participants used the devices. Two 6-point scales included ranging from "Never" to "12-14 days" as well as "Under 10 minutes" to "More than 2 hours".
Measured: 2 weeks
Phase two: Efficacy as described by number of headache days
Measured: 6 Months
Secondary outcomes (3)
Phase two: Headache Disability Inventory
Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability
Measured: 6 Months
Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250
Will be measuring serum samples prior to study and at 12-week time to assess for change
Measured: baseline and 12 weeks
Anxiety and Depression
Migraine related anxiety and depression will be assessed by PROMIS29
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start30 Sep 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups, treatment as usual and active intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn A. Bernstein, Brigham and Women's Hospital
- Investigators
- carolyn bernstein, MD, Principal investigator, BWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599228
- Sponsor's protocol ID
- 2026P000879
- Acronym
- MIRAGE
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share demographics including age and sex within the BWH researchers.
Publications
Yamanaka G, Hayashi K, Morishita N, Takeshita M, Ishii C, Suzuki S, Ishimine R, Kasuga A, Nakazawa H, Takamatsu T, Watanabe Y, Morichi S, Ishida Y, Yamazaki T, Go S. Experimental and Clinical Investigation of Cytokines in Migraine: A Narrative Review. Int J Mol Sci. 2023 May 6;24(9):8343. doi: 10.3390/ijms24098343.
PubMed 37176049Viderman D, Tapinova K, Dossov M, Seitenov S, Abdildin YG. Virtual reality for pain management: an umbrella review. Front Med (Lausanne). 2023 Jul 14;10:1203670. doi: 10.3389/fmed.2023.1203670. eCollection 2023.
PubMed 37521355Thuraiaiyah J, Erritzoe-Jervild M, Al-Khazali HM, Schytz HW, Younis S. The role of cytokines in migraine: A systematic review. Cephalalgia. 2022 Dec;42(14):1565-1588. doi: 10.1177/03331024221118924. Epub 2022 Aug 12.
PubMed 35962530R P, S C N, S H, K R. Migraine Disability, Quality of Life, and Its Predictors. Ann Neurosci. 2020 Jan;27(1):18-23. doi: 10.1177/0972753120929563. Epub 2020 Jul 3.
PubMed 32982095P AS, S G. Acceptance and Commitment Therapy and Psychological Well-Being: A Narrative Review. Cureus. 2025 Jan 20;17(1):e77705. doi: 10.7759/cureus.77705. eCollection 2025 Jan.
PubMed 39974259Musubire AK, Cheema S, Ray JC, Hutton EJ, Matharu M. Cytokines in primary headache disorders: a systematic review and meta-analysis. J Headache Pain. 2023 Apr 4;24(1):36. doi: 10.1186/s10194-023-01572-7.
PubMed 37016284Aditya S, Rattan A. Advances in CGRP Monoclonal Antibodies as Migraine Therapy: A Narrative Review. Saudi J Med Med Sci. 2023 Jan-Mar;11(1):11-18. doi: 10.4103/sjmms.sjmms_95_22. Epub 2023 Jan 14.
PubMed 36909005
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Intervention Using Reality-Assisted Guided Experience
- ClinicalTrials.gov ID
- NCT07599228
- Acronym / sponsor ID
- MIRAGE / 2026P000879
- Keywords
- acceptance and commitment therapy (ACT), migraine, virtual reality, mindfulness, Calcitonin Gene-Related Peptide monoclonal antibody therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to evaluate the clinical utility of REACT NeuroVR in patients with episodic migraine who are already receiving stable CGRP monoclonal antibody therapy. By combining pharmacologic advances with digitally delivered psychological support, we aim to assess whether this integrated approach can further reduce headache frequency, improve migraine-specific quality of life, and reduce anticipatory anxiety. Additionally, we will explore changes in inflammatory biomarkers to examine potential physiologic correlates of intervention-related improvement.
Ultimately, this study addresses a critical gap in migraine care: the integration of effective, accessible behavioral health strategies into the treatment paradigm for patients who continue to experience burdensome symptoms despite preventive therapy.
- Specific Aims and Objectives
Aim 1 (Pilot and Feasibility Study):
To evaluate the feasibility, acceptability, and usability of personalized Acceptance and Commitment Therapy (ACT) delivered via REACT NeuroVR. Focus groups with key stakeholders (patients, clinicians, and implementation experts) will be conducted to obtain feedback on intervention content, delivery, and outcome measures. Insights from this pilot phase will inform refinements to the intervention and study procedures for the subsequent full-scale clinical trial.
Aim 2 (Primary Efficacy Aim):
To determine whether personalized ACT therapy delivered via REACT NeuroVR reduces the number of monthly headache days in patients with episodic migraine compared to baseline.
Aim 3 (Psychological and Functional Outcomes):
To evaluate whether REACT NeuroVR improves migraine-specific quality of life and reduces anticipatory anxiety related to migraine events.
Aim 4 (Exploratory Biological and Sensory Aims):
To explore changes in inflammatory biomarkers.
Participants will:
Be randomized to treatment as usual or active VR participants Everyone who completes run-in will have a chance to try the VR device and have an additional screen.
Everyone will have a blood test at the beginning and the end of the study. Active participants will be loaned a VR device to take home for four weeks and will do the study activities as well as use a variety of experiences when they choose (such as beach visits, virtual ice baths and others) Participants will fill out surveys throughout the study.
Visit the clinic twice during the study Keep a diary of their symptoms and number of migraines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two groups, treatment as usual and active intervention.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | –This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication |
| Active Treatment | Active comparator | Behavioral: ACT therapy delivered by REACT NeuroVR headsetThis group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults aged 18-80
- Diagnosed with episodic migraine and experience 4-10 migraine days/month
- On a stable dose of CGRP mAb for three months prior
- Satisfy 4 week run-in of 4-10 headaches/month
- Not taking other preventive medications
Key exclusion criteria (5 listed)
- Medication overuse (>10 days/month)
- Vertigo/vestibular dysfunction
- Active psychiatric or neurological comorbidities
- Pregnancy, breastfeeding or planning pregnancy within study timeframe
- Significant visual/hearing/mobility impairment affecting VR use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT therapy delivered by REACT NeuroVR headsetThis is ACT/mindfulness therapy delivered via a virtual reality headset. | Behavioural | Active Treatment |
Primary outcome
Phase one: Qualitative Interview of User Experience
Time frame: 2 weeks
Assessment of user experience captured using open ended questions, yes/no questions, and a 4-point scale ranging from "Very Poor" to "Very Good".
Phase one: rate of participants using virtual reality for migraine-- qualitative data
Time frame: 2 weeks
Assessment of how often and how long participants used the devices. Two 6-point scales included ranging from "Never" to "12-14 days" as well as "Under 10 minutes" to "More than 2 hours".
Phase two: Efficacy as described by number of headache days
Time frame: 6 Months
3 secondary outcomes
Phase two: Headache Disability Inventory
Time frame: 6 Months
Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250
Time frame: baseline and 12 weeks
Anxiety and Depression
Time frame: baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 37176049Yamanaka G, Hayashi K, Morishita N, Takeshita M, Ishii C, Suzuki S, Ishimine R, Kasuga A, Nakazawa H, Takamatsu T, Watanabe Y, Morichi S, Ishida Y, Yamazaki T, Go S. Experimental and Clinical Investigation of Cytokines in Migraine: A Narrative Review. Int J Mol Sci. 2023 May 6;24(9):8343. doi: 10.3390/ijms24098343.
- Background: PubMed 37521355Viderman D, Tapinova K, Dossov M, Seitenov S, Abdildin YG. Virtual reality for pain management: an umbrella review. Front Med (Lausanne). 2023 Jul 14;10:1203670. doi: 10.3389/fmed.2023.1203670. eCollection 2023.
- Background: PubMed 35962530Thuraiaiyah J, Erritzoe-Jervild M, Al-Khazali HM, Schytz HW, Younis S. The role of cytokines in migraine: A systematic review. Cephalalgia. 2022 Dec;42(14):1565-1588. doi: 10.1177/03331024221118924. Epub 2022 Aug 12.
- Background: PubMed 32982095R P, S C N, S H, K R. Migraine Disability, Quality of Life, and Its Predictors. Ann Neurosci. 2020 Jan;27(1):18-23. doi: 10.1177/0972753120929563. Epub 2020 Jul 3.
- Background: PubMed 39974259P AS, S G. Acceptance and Commitment Therapy and Psychological Well-Being: A Narrative Review. Cureus. 2025 Jan 20;17(1):e77705. doi: 10.7759/cureus.77705. eCollection 2025 Jan.
- Background: PubMed 37016284Musubire AK, Cheema S, Ray JC, Hutton EJ, Matharu M. Cytokines in primary headache disorders: a systematic review and meta-analysis. J Headache Pain. 2023 Apr 4;24(1):36. doi: 10.1186/s10194-023-01572-7.
- Background: PubMed 36909005Aditya S, Rattan A. Advances in CGRP Monoclonal Antibodies as Migraine Therapy: A Narrative Review. Saudi J Med Med Sci. 2023 Jan-Mar;11(1):11-18. doi: 10.4103/sjmms.sjmms_95_22. Epub 2023 Jan 14.
- Individual participant dataSharing planned: Yes. We will share demographics including age and sex within the BWH researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
asimina lazaridou, PhD contact
carolyn bernstein, MD principal investigator
BWH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT therapy delivered by REACT NeuroVR headset in people with Migraine Disorders and Migraine With Aura, run by Brigham and Women's Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact carolyn bernstein, MD (6177329700, cabernstein@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase one: Qualitative Interview of User Experience (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07599228, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.