NCT02072642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

9.9 years

First QC Date

February 24, 2014

Last Update Submit

August 10, 2023

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III

    5 weeks

Study Arms (2)

Active light therapy (10,000 lux)

ACTIVE COMPARATOR

Light therapy: DayVia lamp 10000 lux

Device: active light therapy : Light therapy: DayVia lamp 10000 lux

Placebo light therapy (70 lux)

PLACEBO COMPARATOR

Placebo light therapy

Device: Placebo light therapy

Interventions

active light therapy : Light therapy: DayVia lamp 10000 luxDEVICE

4 weeks of active light therapy with DayVia lamp 10000 lux

Active light therapy (10,000 lux)
Placebo light therapyDEVICE

4 weeks with Placebo light therapy

Placebo light therapy (70 lux)

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic Parkison's Disease, low or moderately severe
  • Hoehn\&Yahr \<4
  • to \< 15 years of evolution·
  • Between 45-75 years old
  • Absence of dementia : MMSE \> 23·
  • No severe depression

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Strasbourg, france

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Patrice BOURGIN, MD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2014

First Posted

February 26, 2014

Study Start

April 1, 2013

Primary Completion

March 10, 2023

Study Completion

May 1, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)