Using Virtual Reality to Teach Mindfulness to People With Migraine (MIRAGE)
Migraine Intervention Using Reality-Assisted Guided Experience
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: carolyn bernstein, MD
- Número de teléfono: 6177329700
- Correo electrónico: cabernstein@bwh.harvard.edu
Copia de seguridad de contactos de estudio
- Nombre: asimina lazaridou, PhD
- Correo electrónico: alazaridou@bwh.harvard.edu
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02155
- Brigham and Womens Hospital
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Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Brigham and Women's Hospital
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Chestnut Hill, Massachusetts, Estados Unidos, 02467
- Brigham and Women's Health Care Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Treatment as usual
This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication
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Comparador activo: Active Treatment
This group will participate in the four week active virtual reality treatment and will also remain on their CGRP mAb medication.
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This is ACT/mindfulness therapy delivered via a virtual reality headset.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase one: Qualitative Interview of User Experience
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Phase two: Efficacy as described by number of headache days
Periodo de tiempo: 6 Months
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6 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase two: Headache Disability Inventory
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: carolyn bernstein, MD, BWH
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026P000879
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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