Light Therapy in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
active light therapy : Light therapy: DayVia lamp 10000 lux
Placebo light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
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
Sites / Locations
- University Hospital, Strasbourg, france
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active light therapy (10,000 lux)
Placebo light therapy (70 lux)
Arm Description
Light therapy: DayVia lamp 10000 lux
Placebo light therapy
Outcomes
Primary Outcome Measures
Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III
Secondary Outcome Measures
Full Information
NCT ID
NCT02072642
First Posted
February 24, 2014
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT02072642
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
May 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active light therapy (10,000 lux)
Arm Type
Active Comparator
Arm Description
Light therapy: DayVia lamp 10000 lux
Arm Title
Placebo light therapy (70 lux)
Arm Type
Placebo Comparator
Arm Description
Placebo light therapy
Intervention Type
Device
Intervention Name(s)
active light therapy : Light therapy: DayVia lamp 10000 lux
Intervention Description
4 weeks of active light therapy with DayVia lamp 10000 lux
Intervention Type
Device
Intervention Name(s)
Placebo light therapy
Intervention Description
4 weeks with Placebo light therapy
Primary Outcome Measure Information:
Title
Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice BOURGIN, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Strasbourg, france
City
Strasbourg
ZIP/Postal Code
67000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Light Therapy in Parkinson's Disease
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