Migraine Intervention Using Reality-Assisted Guided Experience
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Carolyn A. Bernstein
Lavine Family Endowed Chair in Neurology
Brigham and Women's Hospital
