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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
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 24, 2014
Last Updated
August 10, 2023
Sponsor
University Hospital, Strasbourg, France
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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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