MRI Outcomes of Mindfulness Meditation for Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 4
- 主要终点
- Change in headache frequency and impact
研究概览
简要总结
112 migraine subjects will be initially randomly assigned to Mindfulness-Based Stress Reduction (MBSR) or a Stress Management for Headache group (SMH). Outcomes, including headache frequency and impact and brain activity, will be assessed at baseline, prior to intervention, and at 3-, 6-, and 12-months.
详细描述
Subjects in the MBSR group undergo a standardized 8-week MBSR course plus an additional 4 sessions over another 8 weeks that further emphasize and train subjects on MBSR concepts and skills. The SMH group will have 12 sessions spread out in a similar fashion to MBSR. Clinical outcomes are compared between groups at 3, 6, and 12 months to assess efficacy of MBSR. MRI scans are performed at baseline, 3 months, and 6 months changes in MRI metrics after MBSR and changes in MRI metrics associated with long-term MBSR practice. 30 healthy controls will also undergo MRI scanning to determine abnormal brain activity and structure in migraineurs compared to healthy controls across the 6 month period of observation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in headache frequency and impact
时间窗: Baseline, 3, 6, and 12 months
Headache days per 28 days and headache-related disability (HIT-6)
Change in gray matter volume
时间窗: Baseline, 3, and 6 months
Gray matter volume in the insula, dorsolateral prefrontal cortex, and cingulate
Change in Brain Function
时间窗: Baseline, 3, and 6 months
Overall activation of the dorsolateral prefrontal cortex and the task-positive cognitive network, and resting state connectivity to the insula
次要结局
- Change in Whole Brain Function(Baseline, 3, and 6 months)
- Change in headache intensity(Baseline, 3, 6, and 12 months)
- Change in Brain Structure(Baseline, 3, and 6 months)