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临床试验/NCT02072642
NCT02072642已完成不适用

Light Therapy in Parkinson's Disease : Effect on Motor Symptoms, Sleep, Circadian Rhythms, and Mood

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年4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
44
试验地点
2
主要终点
Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III

研究概览

简要总结

Parkinson's disease, a degenerative disorder of the dopaminergic system, combines motor symptoms but also non-motor, such as depression, sleep disorders and circadian rhythms and impaired cognitive functions. Difficulties in balancing the dopaminergic treatment of these patients emphasizes the need to find effective adjuvant therapies. Light therapy (LT) represents one such innovative therapeutic approach. Although light has an obvious to visual pathways within the brain, today it is known to additionally exert non-visual effects throughout the body. Recently our team has shown that non-visual, non-circadian light plays a major role in the regulation of sleep, as well as cognitive brain function in general. The retina, the primary conduit for the transmission of light information is weakened or thinned in Parkinson's patients. The dopamine system is known to enhance the processing of light information and intraocular injection of L-dopa in animal models of Parkinson's disease, can reverse associated motor symptoms. This allows for the possibility that LT would strengthen the dopaminergic tone in the central nervous system. However, to this date its effectiveness for alleviating Parkinson's symptoms has only been suggested by two studies, both poorly controlled. Thus, through the convergence of basic and clinical data, a study examining the effect of LT directly in people Parkinson's disease symptoms, whilst controlling for the effects on sleep, circadian system, mood, and cognitive functioning, is of extreme importance. With this information our hope is to determine if these polymorphisms allow for a predictive model of response to LT treatment.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Idiopathic Parkison's Disease, low or moderately severe
  • Hoehn&Yahr <4
  • 4 to < 15 years of evolution·
  • Between 45-75 years old
  • Absence of dementia : MMSE > 23·
  • No severe depression
  • Stable medication levels during the 5 weeks before inclusion

排除标准

  • Secondary or severe Parkinson's disease
  • Ocular pathologies (i.e. retinopathy)
  • Photosensitive medication
  • Antidepressant treatment·
  • Major depression syndrome
  • MMSE < 23
  • Circadian rhythm problems
  • Sleep apnea syndrome
  • Manifested or acute psychiatric comorbidities
  • Pregnant women

结局指标

主要结局

Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III

时间窗: 5 weeks

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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