- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02072642
Light Therapy in Parkinson's Disease
August 10, 2023 updated by: University Hospital, Strasbourg, France
Light Therapy in Parkinson's Disease : Effect on Motor Symptoms, Sleep, Circadian Rhythms, and Mood
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Strasbourg, France, 67000
- University Hospital, Strasbourg, France
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active light therapy (10,000 lux)
Light therapy: DayVia lamp 10000 lux
|
4 weeks of active light therapy with DayVia lamp 10000 lux
|
|
Placebo Comparator: Placebo light therapy (70 lux)
Placebo light therapy
|
4 weeks with Placebo light therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III
Time Frame: 5 weeks
|
5 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Patrice BOURGIN, MD, University Hospital, Strasbourg, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2013
Primary Completion (Actual)
March 10, 2023
Study Completion (Actual)
May 1, 2023
Study Registration Dates
First Submitted
February 24, 2014
First Submitted That Met QC Criteria
February 25, 2014
First Posted (Estimated)
February 26, 2014
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 10, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.