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Completed

NCT Number: NCT02072642

Light Therapy in Parkinson's Disease

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.

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Key information

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

active light therapy : Light therapy: DayVia lamp 10000 lux

Device

4 weeks of active light therapy with DayVia lamp 10000 lux

Placebo light therapy

Device

4 weeks with Placebo light therapy

Primary outcomes

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

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2014
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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