Using Virtual Reality to Teach Mindfulness to People With Migraine (MIRAGE)
Migraine Intervention Using Reality-Assisted Guided Experience
연구 개요
상태
상세 설명
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
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: carolyn bernstein, MD
- 전화번호: 6177329700
- 이메일: cabernstein@bwh.harvard.edu
연구 연락처 백업
- 이름: asimina lazaridou, PhD
- 이메일: alazaridou@bwh.harvard.edu
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02155
- Brigham and Womens Hospital
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Chestnut Hill, Massachusetts, 미국, 02467
- Brigham and Women's Hospital
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Chestnut Hill, Massachusetts, 미국, 02467
- Brigham and Women's Health Care Center
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Treatment as usual
This group will remain on their CGRP injectable monoclonal antibody migraine preventive medication
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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Phase one: Qualitative Interview of User Experience
기간: 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
기간: 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
기간: 6 Months
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6 Months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Phase two: Headache Disability Inventory
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: carolyn bernstein, MD, BWH
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026P000879
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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