Clinical trial NCT02072642: Light Therapy in Parkinson's Disease
Official title: Light Therapy in Parkinson's Disease : Effect on Motor Symptoms, Sleep, Circadian Rhythms, and Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, france
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Patrice BOURGIN, MD
role: PRINCIPAL_INVESTIGATOR
References: