Parkinson's DiseaseNCT02072642
Light Therapy in Parkinson's Disease
A study testing active light therapy : Light therapy: DayVia lamp 10000 lux in people with Parkinson's Disease, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- active light therapy : Light therapy: DayVia lamp 10000 lux
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Secondary or severe Parkinson's disease
- Ocular pathologies (i.e. retinopathy)
- Photosensitive medication
- Antidepressant treatment·
- Major depression syndrome
- MMSE < 23
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- Circadian rhythm problems
- Sleep apnea syndrome
- Manifested or acute psychiatric comorbidities
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Parkinson's Disease
- Being tested
- active light therapy : Light therapy: DayVia lamp 10000 lux, Placebo light therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active light therapy : Light therapy: DayVia lamp 10000 luxDevice
4 weeks of active light therapy with DayVia lamp 10000 lux
Placebo light therapyDevice
4 weeks with Placebo light therapy
| Study group | Role | What they receive |
|---|---|---|
| Active light therapy (10,000 lux) | Active comparator | Light therapy: DayVia lamp 10000 lux Receives: Device: active light therapy : Light therapy: DayVia lamp 10000 lux |
| Placebo light therapy (70 lux) | Placebo comparator | Placebo light therapy Receives: Device: Placebo light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startApr 2013
- Primary completion10 Mar 2023
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice BOURGIN, MD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072642
- Sponsor's protocol ID
- 5063
- Status last verified
- Aug 2023
- First submitted
- 24 Feb 2014
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy in Parkinson's Disease : Effect on Motor Symptoms, Sleep, Circadian Rhythms, and Mood
- ClinicalTrials.gov ID
- NCT02072642
- Acronym / sponsor ID
- 5063
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active light therapy (10,000 lux) | Active comparator | Device: active light therapy : Light therapy: DayVia lamp 10000 luxLight therapy: DayVia lamp 10000 lux |
| Placebo light therapy (70 lux) | Placebo comparator | Device: Placebo light therapyPlacebo light therapy |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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·
Key exclusion criteria (10 listed)
- Secondary or severe Parkinson's disease
- Ocular pathologies (i.e. retinopathy)
- Photosensitive medication
- Antidepressant treatment·
- Major depression syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active light therapy : Light therapy: DayVia lamp 10000 lux4 weeks of active light therapy with DayVia lamp 10000 lux | Device | Active light therapy (10,000 lux) |
| Placebo light therapy4 weeks with Placebo light therapy | Device | Placebo light therapy (70 lux) |
Primary outcome
Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice BOURGIN, MD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active light therapy : Light therapy: DayVia lamp 10000 lux in people with Parkinson's Disease, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global score :Unified Parkinson's Disease Rating Scale (UPDRS) I II III (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.