Photobiomodulation Therapy in Persons With Multiple Sclerosis
赞助:
Marquette University
合作者:
信息的提供 (责任方):
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| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | April 30, 2018 | ||
| 预计主要完成日期 | April 29, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Muscle Fatigue[ Time Frame: up to 4 week photobiomodulation intervention, immediately after the intervention, and then 4 months after this extended treatment ] Change in muscle fatigue or recovery after photobiomodulation therapy |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Photobiomodulation Therapy in Persons With Multiple Sclerosis | ||
| 正式标题 ICMJE | Effect of Photobiomodulation Therapy on Muscle Function and Inflammation in Persons With Multiple Sclerosis | ||
| 简要概况 | This study will test whether photobiomodulation therapy improves muscle endurance and decreases inflammation in persons with relapsing-remitting multiple sclerosis. We will also investigate mechanisms for any improvements. |
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| 详细说明 | Persons with multiple sclerosis (MS) MS commonly experience muscle weakness and fatigue which may contribute to the commonly reported symptomatic fatigue. Photobiomodulation therapy (PBMT) induced with light in the visible red to near infrared (VIS/NIR) region of the spectrum (600-1000 nm) can stimulate cytochrome c oxidase and improve mitochondrial function. PBMT is an emerging therapeutic modality for soft tissue injury, chronic inflammation, neurodegeneration , and retinal diseases. PBMT has also been used to enhance muscle endurance, strength and recovery in healthy adults. We propose that in persons with MS, PBMT will 1) enhance regional muscle endurance after acute treatment and 2) enhance functional endurance after extended treatment. We will also test to determine if improvements are due to central or peripheral neuromuscular or cardiovascular mechanisms. Final, we will explore if regional PBMT can result in systemic anti-inflammatory effects. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Supportive Care |
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| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
30 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | August 31, 2019 | ||
| 预计主要完成日期 | April 29, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: 1. Relapsing remitting MS, 2. Independent or ambulatory with minimal aid. 3. Must be able to move foot (ankle dorsiflexion) at least moderately forcibly against gravity (manual muscle test score 3-5) 4. Subjects must be able to walk for 6 minutes independently with no or minimal use of an assistive device. Exclusion Criteria: 1. No noticeable left right ankle strength asymmetry 2. No exacerbations (MS attacks) or immunosuppressive therapy use within the previous 6 months 3. No concurrent infection or known cardiovascular disease including having a pacemaker; or other serious medical co-morbidity including metabolic, mitochondrial, autoimmune, diseases or other co-existing neurologic conditions. 4. Not involved in any clinical trial or other research that could confound results. 5. Must not be pregnant 6. Must not have an active diagnosis of cancer | ||
| 性别 |
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| 年龄 | 最小年龄：20 Years ，最大年龄：60 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | ， | ||
| 研究赞助商 ICMJE | Marquette University | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | |||
| 验证日期 | September 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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