NCT01613872已完成不适用
The Effects of Mindfulness Based Stress Reduction on Patients With Traumatic Brain Injury
Spaulding Rehabilitation Hospital2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Feasibility and Safety
研究概览
简要总结
This study is studying the effects of Mindfulness Based Stress Reduction (MBSR), a standard protocol of gentle yoga and breath meditation, on patients with Traumatic Brain Injury (TBI). The investigators are testing whether this intervention can help improve the stress response and increase resiliency and mindfulness for patients with TBI, which may lead to improved symptoms and neurocognitive function.
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
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •TBI > 1 year prior to enrollment
- •Ages 30-50
- •Right handed participants
- •History of acute inpatient rehabilitation stay of ≥ 1 night
排除标准
- •Non-English speaking (because this is a group intervention, it requires a common language)
- •Dependent with activities of daily living (ADLs)
- •Phone screen (TICS-1) > 30
- •Rivermead Post-Concussion Questionnaire Score < 21
- •Actively practicing meditation and/or yoga or have taken a meditation/yoga class in the last 12 months
- •Signs or symptoms of upper motor neuron syndrome
- •Any major major systemic illness or unstable condition which could interfere with protocol compliance, including the diagnosis of major depression
- •Active psychiatric disease that would interfere with participation in the trial
- •Psychotic features, agitation, or behavioral problems within the last 3 months
- •History of alcohol/substance abuse or dependence within the past 2 years
- •Neurosurgical intervention affecting brain parenchyma
- •Reported sequelae from brain lesions or head trauma prior to most recent brain injury
- •Seizure activity or treatment for seizures
- •Use of investigational agents
- •Participating in other clinical studies involving neuropsychological measures collected more than one time per year
- •Any involvement in legal matters (workers' compensation, litigation, et al), past, present, or anticipated in the future, related to the TBI
- •Unable to undergo MRI for any reason such as claustrophobia, presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body
结局指标
主要结局
Feasibility and Safety
时间窗: 8 weeks
Benchmark measurements of attendance, home practice, adverse events, and focused interviews
次要结局
- Questionnaires(8 weeks)
- Neuropsychological Testing(8 weeks)
- Advanced MRI(8 weeks)
研究者
Ross D. Zafonte, MD
Chair, Physical Medicine and Rehabilitation
Spaulding Rehabilitation Hospital
研究点 (2)
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