Using Virtual Reality to Teach Mindfulness to People With Migraine (MIRAGE)
Migraine Intervention Using Reality-Assisted Guided Experience
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: carolyn bernstein, MD
- Telefonnummer: 6177329700
- E-post: cabernstein@bwh.harvard.edu
Studera Kontakt Backup
- Namn: asimina lazaridou, PhD
- E-post: alazaridou@bwh.harvard.edu
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02155
- Brigham and Womens Hospital
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Chestnut Hill, Massachusetts, Förenta staterna, 02467
- Brigham and Women's Hospital
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Chestnut Hill, Massachusetts, Förenta staterna, 02467
- Brigham and Women's Health Care Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Treatment as usual
This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication
|
|
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase one: Qualitative Interview of User Experience
Tidsram: 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".
|
2 weeks
|
|
Phase one: rate of participants using virtual reality for migraine-- qualitative data
Tidsram: 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".
|
2 weeks
|
|
Phase two: Efficacy as described by number of headache days
Tidsram: 6 Months
|
6 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase two: Headache Disability Inventory
Tidsram: 6 Months
|
Assessment of acceptance and commitment (ACT) treatment on migraine-associated disability
|
6 Months
|
|
Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250
Tidsram: baseline and 12 weeks
|
Will be measuring serum samples prior to study and at 12-week time to assess for change
|
baseline and 12 weeks
|
|
Anxiety and Depression
Tidsram: baseline and 12 weeks
|
Migraine related anxiety and depression will be assessed by PROMIS29
|
baseline and 12 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: carolyn bernstein, MD, BWH
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026P000879
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
- CSR
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