Brain Mechanisms of Vagus Nerve Stimulation and Stress Reduction Training for Migraine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Brain Activity Changes in Migraine Patients in Response to Treatment
研究概览
简要总结
This study design has two components: 1) a cross-sectional assessment of brain activity and inflammation in migraine patients compared to healthy controls and 2) an assessment of 8 weeks of a combination therapy approach to treating migraine.
详细描述
Chronic pain is the most prevalent and disabling medical condition, and no single therapy has proven to be completely successful for alleviating pain, such as migraine headache. It is well documented, and recommended in the recent Institute of Medicine (IOM) report, that a multimodal approach is optimal for pain management. This study will evaluate a combination transcutaneous vagus nerve stimulation and stress reduction training for migraine.
Investigators will recruit participants who have migraines and randomize to one of four potential treatment arms (real or sham stimulation + real or sham stress reduction training). Brain imaging (MRI and PET) and clinical data will be collected before and after 8 weeks of the combination therapy.
Healthy controls will also be recruited for collection of the same baseline brain imaging and clinical data, but with no treatment or second data collection phase.
Findings from this research will help elucidate brain activity and inflammation associated with migraines and evaluate the efficacy of the combination therapy in reducing migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, 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
- •Subjects must be between 18 and 65 years of age.
- •Migraine Diagnosis and general health otherwise.
- •Willingness to attend twice- weekly treatment session at Cambridge Health Alliance for 8 weeks.
- •Able to give written consent and participate in group interventions in English.
- •Healthy Volunteers between the ages of 18 and 65 can participate in this study.
排除标准
- •Major illness, psychiatric condition, or neurological disease.
- •Previous experience with stress reduction training (such as mindfulness training, MBSR, MBCT, Relaxation Response) or more than 15 home mediation practice sessions in the past month, or more than 10 classes in yoga, Tai Chi, or Qi Gong in the past 3 months
- •Any condition that would prohibit MRI scanning
- •Healthy Volunteers have the same eligibility constraints with the addition of current or past history of migraine.
研究组 & 干预措施
sham tVNS + SRT A
sham stimulation and Stress Reduction Training A
干预措施: sham tVNS (Device)
active tVNS + SRT A
active tVNS and Stress Reduction Training A
干预措施: Stress Reduction Training A (Behavioral)
active tVNS + SRT A
active tVNS and Stress Reduction Training A
干预措施: active tVNS (Device)
active tVNS + SRT B
active tVNS and Stress Reduction Training B
干预措施: active tVNS (Device)
active tVNS + SRT B
active tVNS and Stress Reduction Training B
干预措施: Stress Reduction Training B (Behavioral)
sham tVNS + SRT A
sham stimulation and Stress Reduction Training A
干预措施: Stress Reduction Training A (Behavioral)
sham tVNS + SRT B
sham tVNS and Stress Reduction Training B
干预措施: Stress Reduction Training B (Behavioral)
sham tVNS + SRT B
sham tVNS and Stress Reduction Training B
干预措施: sham tVNS (Device)
结局指标
主要结局
Brain Activity Changes in Migraine Patients in Response to Treatment
时间窗: 8 weeks (i.e. post-treatment)
Post-treatment versus baseline change in intervention-evoked cortical amplification ratio (left posterior insula to spinal trigeminal nucleus ratio of fMRI BOLD percent signal change) for trigeminal afferent stimulation (i.e. forehead stimulation).
Brain Inflammation Changes in Migraine Patients in Response to Treatment
时间窗: 8 weeks (post-treatment)
PET \[11C\]PBR28 signal, quantified as Standardized Uptake Value Ratio (SUVR; i.e., tissue radioactivity / injected dose / weight) change from baseline to post-treatment, compared across treatment groups for migraine patients. \[11C\]PBR28 SUVR was measured in the insula (average of left and right insula), using cerebellum SUV as a pseudo-reference region.
次要结局
- Brain Activity Differences Between Migraine Patients and Healthy Controls(Week 0-3 (Baseline window))
- Brain Inflammation Differences Between Migraine Patients and Healthy Controls(Week 0-3 (Baseline window))
研究者
Vitaly Napadow, Ph.D., Lic.Ac.
Associate Professor
Massachusetts General Hospital