Light Therapy in Parkinson's Disease

NCT ID: NCT02072642

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2023-05-31

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active light therapy (10,000 lux)

Light therapy: DayVia lamp 10000 lux

Group Type: ACTIVE_COMPARATOR

active light therapy : Light therapy: DayVia lamp 10000 lux

Intervention Type: DEVICE

4 weeks of active light therapy with DayVia lamp 10000 lux

Placebo light therapy (70 lux)

Placebo light therapy

Group Type: PLACEBO_COMPARATOR

Placebo light therapy

Intervention Type: DEVICE

4 weeks with Placebo light therapy

Interventions

active light therapy : Light therapy: DayVia lamp 10000 lux

4 weeks of active light therapy with DayVia lamp 10000 lux

Intervention Type: DEVICE

Placebo light therapy

4 weeks with Placebo light therapy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrice BOURGIN, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Strasbourg, France

Locations

University Hospital, Strasbourg, france

Strasbourg, , France

Countries

France

Other Identifiers

5063

Identifier Type: -

Identifier Source: org_study_id