Using Virtual Reality to Teach Mindfulness to People With Migraine

Официальное название

Migraine Intervention Using Reality-Assisted Guided Experience

Обзор

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.

Подробное описание

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

Вмешательства

• Поведенческое ACT therapy delivered by REACT NeuroVR headset
  This is ACT/mindfulness therapy delivered via a virtual reality headset.

Первичные конечные точки

• Phase one: Qualitative Interview of User Experience [Срок оценки: 2 weeks]
• Phase one: rate of participants using virtual reality for migraine-- qualitative data [Срок оценки: 2 weeks]
• Phase two: Efficacy as described by number of headache days [Срок оценки: 6 Months]

Вторичные конечные точки (3)

• Phase two: Headache Disability Inventory [Срок оценки: 6 Months]
• Phase two: Change in Inflammatory Biomarker panel-NULISAseq Inflammation 250 [Срок оценки: baseline and 12 weeks]
• Anxiety and Depression [Срок оценки: baseline and 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Brigham and Womens Hospital — Boston
• Brigham and Women's Health Care Center — Chestnut Hill
• Brigham and Women's Hospital — Chestnut Hill

Публикации

• 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. PMID 37176049
• 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. PMID 37521355
• 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. PMID 35962530
• 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. PMID 32982095
• 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. PMID 39974259
• 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. PMID 37016284
• 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. PMID 36909005

Идентификаторы

NCT: NCT07599228 · 2026P000879

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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