Using Virtual Reality to Teach Mindfulness to People With Migraine (MIRAGE)
Migraine Intervention Using Reality-Assisted Guided Experience
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
1. 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
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: carolyn bernstein, MD
- Telefonnummer: 6177329700
- E-mail: cabernstein@bwh.harvard.edu
Undersøgelse Kontakt Backup
- Navn: asimina lazaridou, PhD
- E-mail: alazaridou@bwh.harvard.edu
Studiesteder
-
-
Massachusetts
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Boston, Massachusetts, Forenede Stater, 02155
- Brigham and Womens Hospital
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Chestnut Hill, Massachusetts, Forenede Stater, 02467
- Brigham and Women's Hospital
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Chestnut Hill, Massachusetts, Forenede Stater, 02467
- Brigham and Women's Health Care Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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
- Able and willing to use VR device
- No history of significant psychiatric illness
- Willing to comply with study procedures
- English-speaking
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Treatment as usual
This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication
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|
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Aktiv komparator: Active Treatment
This group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication.
|
This is ACT/mindfulness therapy delivered via a virtual reality headset.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase one: Qualitative Interview of User Experience
Tidsramme: 2 weeks
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Assessment of user experience captured using open ended questions, yes/no questions, and a 4-point scale ranging from "Very Poor" to "Very Good".
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2 weeks
|
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Phase one: rate of participants using virtual reality for migraine-- qualitative data
Tidsramme: 2 weeks
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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".
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2 weeks
|
|
Phase two: Efficacy as described by number of headache days
Tidsramme: 6 Months
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6 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Phase two: Headache Disability Inventory
Tidsramme: 6 Months
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Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability
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6 Months
|
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Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250
Tidsramme: baseline and 12 weeks
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Will be measuring serum samples prior to study and at 12-week time to assess for change
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baseline and 12 weeks
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Anxiety and Depression
Tidsramme: baseline and 12 weeks
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Migraine related anxiety and depression will be assessed by PROMIS29
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baseline and 12 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: carolyn bernstein, MD, BWH
Publikationer og nyttige links
Generelle publikationer
- R 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.
- Thuraiaiyah 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.
- Musubire 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.
- 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.
- Viderman 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.
- P 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.
- Aditya 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026P000879
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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