NCT01857219Unknown不适用
A Brain Imaging Study of Tai Chi on Fibromyalgia
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Arterial spin labeling (ASL) before and after Tai Chi intervention.
研究概览
简要总结
To accomplish our Specific Aims, we propose to conduct a two-session fMRI experiment in up to 30 patients with fibromyalgia (FM) and up to 30 healthy controls. All subjects will be invited to complete the second, identical fMRI session about 3 months following completion of the first session. Fibromyalgia subjects will complete their scans before and after a 12-week Tai Chi intervention in collaboration with Tufts Medical Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers 18-50 years of age.
- •Fibromyalgia for at least the past 3 months, as determined by the referring physician.
- •At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
排除标准
- •Specific causes of pain (e.g., cancer, fractures, spinal stenosis, infections)
- •History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
- •Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
- •Criteria for healthy adults.
- •Inclusion Criteria:
- •Volunteers 18-50 years of age.
- •At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
- •Exclusion Criteria:
- •Chronic and acute pain (ex. Fibromyalgia).
- •History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
- •Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
结局指标
主要结局
Arterial spin labeling (ASL) before and after Tai Chi intervention.
时间窗: 12 weeks
A method to assess cerebral blood flow change (at rest) through functional magnetic in resonance imaging in response to Tai Chi intervention.
次要结局
- Resting-state BOLD fMRI before and after Tai Chi intervention.(12 weeks)
研究者
Jian Kong
Assistant Professor
Massachusetts General Hospital
研究点 (2)
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