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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02072642
Other study ID # 5063
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2013
Est. completion date May 2023

Study information

Verified date August 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date May 2023
Est. primary completion date March 10, 2023
Accepts healthy volunteers No
Gender All
Age group 45 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
active light therapy : Light therapy: DayVia lamp 10000 lux
4 weeks of active light therapy with DayVia lamp 10000 lux
Placebo light therapy
4 weeks with Placebo light therapy

Locations

Country Name City State
France University Hospital, Strasbourg, france Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III 5 weeks
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