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临床试验/NCT03691766
NCT03691766已完成不适用

Effect of Photobiomodulation Therapy on Muscle Function and Inflammation in Persons With Multiple Sclerosis

Marquette University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
Muscle Fatigue

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Relapsing remitting MS,
  • •Independent or ambulatory with minimal aid.
  • •Must be able to move foot (ankle dorsiflexion) at least moderately forcibly against gravity (manual muscle test score 3-5)
  • •Subjects must be able to walk for 6 minutes independently with no or minimal use of an assistive device.

排除标准

  • •No noticeable left right ankle strength asymmetry
  • •No exacerbations (MS attacks) or immunosuppressive therapy use within the previous 6 months
  • •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.
  • •Not involved in any clinical trial or other research that could confound results.
  • •Must not be pregnant
  • •Must not have an active diagnosis of cancer

研究组 & 干预措施

Photobiomodulation Therapy

Experimental

Experimental: Photobiomodulation Therapy comprising 640 nm, 875 nm, and 905 nm light (red lights)

干预措施: Photobiomodulation Therapy (Other)

Control

Placebo Comparator

Placebo device with different wavelengths of light without known physiologic effect.

干预措施: Placebo (Other)

结局指标

主要结局

Muscle Fatigue

时间窗: 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

次要结局

  • Systemic Inflammation(up to 4 week photobiomodulation intervention, and then again at 4 months post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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