Exploring the Effect of the Transcendental Meditation® Technique on Migraine Frequency, Intensity, and Functionality: A Single-Arm Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Frequency and functionality
研究概览
简要总结
This research will explore the effect of the Transcendental Meditation® Technique on migraine intensity and frequency. It will be a single-arm pilot study involving 30 participants recruited from migraine treatment facilities and support groups in the US.
详细描述
The objective of this study is to assess the safety, feasibility, and effects of the practice of the Transcendental Meditation technique in adults with migraines. This study will involve 30 participants recruited from migraine treatment facilities and migraine support groups in the US. The study will span three months, with all participants practicing Transcendental Meditation (TM) while continuing their usual lifestyle and medication regimen. Pre-data will be collected through symptom analysis, headache patterns, and evaluation questionnaires. All potential subjects will keep a daily migraine diary for 30 days before inclusion in the study, both to assess migraine status and to adhere to study protocols during the study. All the subjects will receive TM instruction, followed by bi-weekly group meetings and one-on-one sessions for 3 months to monitor progress and ensure correct practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of migraine with or without aura, based on ICHD3 criteria
- •4 and above migraine days/month.
- •· Episodic (4-14) vs chronic migraine (15+)
- •≥ one-year history of migraines starting before the age of
- •≥ 18 years old or ≤ 60 Years old
- •Willing to attend follow-up sessions.
- •Willing to practice TM twice a day for 20 minutes.
- •Fluent in English.
- •Willing to continue the same medication without any additional medicine
- •In good general health, with no other diseases expected to interfere with the study.
排除标准
- •> 60 years old or < 18 Years old
- •Already practicing Transcendental Meditation.
- •Pre-diagnosed major systemic illness or unstable medical/psychiatric condition (eg, suicide risk) requiring immediate treatment or that could compromise protocol adherence
- •Medication overuse headache (MOH)
- •Current/planned pregnancy or breastfeeding
- •New prophylactic migraine medicine started within 4 weeks of the screening visit
- •Unwilling to maintain stable migraine medication dosages
- •Failure to complete baseline headache logs.
研究组 & 干预措施
Exploring the Effect of the Transcendental Meditation® Technique on Migraine
干预措施: Meditation (Behavioral)
结局指标
主要结局
Frequency and functionality
时间窗: 6 Months
Frequency and functionality will be measured by the data recorded in the migraine App.
The Migraine Disability Assessment (MIDAS) to measure frequency and functionality.
时间窗: 6 Months
Migraine Specific Quality of Life Questionnaire (MSQ), version 2.1 to measure impact on Quality of Life
时间窗: 6 Months
Questionnaire (MSQ), version 2.1 to measure impact on functionality.
时间窗: 6 months
次要结局
未报告次要终点
研究者
Fred Travis
Director, Brain Center and PhD Chair of the Department of Maharishi Vedic Science at Maharishi University of Management
Maharishi International University