Below is some information from clinicaltrials.gov about a light therapy trial that will begin recruitment soon. I have also included an email response from the contact listed on clinicaltrials.gov. you should be able to see the trial at clinicaltrials.gov if you copy and paste the https: address in your browser.
DB RCT for Specialized Phototherapy in Parkinson's Disease. (LIGHT-PD)
clinicaltrials.gov/ct2/show...
Study Description
Brief Summary:
This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment.
Condition or disease Intervention/treatment Phase
Parkinson Disease
Device: Celeste Specialized Phototherapy Device
Detailed Description:
Six month double blind, randomized controlled study with virtual clinic visits at baseline, week 13 and week 26. The Celeste specialized phototherapy device is similar to a tablet with a stand that allows the device to be angled towards the participant's face. The light is to be used each evening in the home for 1 hour, while the participant watches TV, eats dinner, reads, etc. The primary outcome measure is Parts 1 and 2 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS Parts 1 and 2 measure non-motor and motor function in Parkinson's. Participants will be assessed via online videoconferences.
Study Type :Interventional (Clinical Trial)
Estimated Enrollment :200 participants
Allocation:Randomized
Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Inclusion Criteria:
- Diagnosis of Parkinson's disease as determined by the study PI, in keeping with the UK PD Society Brain Bank Criteria for the Diagnosis of PD
- Responsiveness to dopaminergic medication, as judged by the rater, and have been using treatment for at least the past 1 year
- Relatively good eyesight as attested to by participants (Corrective lenses of at least 20/60)
- Stable levodopa and other anti-PD medications for at least 28 days prior to screening -
Exclusion Criteria:
- Diagnosis of an atypical Parkinsonian syndrome
- More than 50% of the waking day spent in the OFF state
- More than 25% (>4 hours/day) of bothersome dyskinesias
- An anticipated need for a change in dopamine replacement therapy, concomitant medications, OTC/supplements, or other alternative therapies during the participant's involvement in the investigation
- History of previous light therapy use for PD
Here is the email response from the CT.gov contact Dan Adams that I received today - June 24, 2021:
The trial hasn’t started yet, and it is a national trial, so anywhere you are in the US, you would be able to participate. The eligibility requirements are pretty inclusive too. But you do need to be on a stable dose of Parkinson’s medication, and you need to have been on medication for at least a year. You’re probably aware that this trial is looking at improving non-motor symptoms in PD, as well as other motor, but the focus is investigating improving things like sleep, cognition, daytime sleepiness, fatigue, depression, anxiety, irritability, apathy, urinary problems, etc.
We will probably start recruiting patients in the early fall, and recruitment will take several months, so you will likely be able to participate.
Best,
Dan
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Dan Adams
Science Officer
M 801.494.7804 O 801.770.6960
dan.adams@photopharmics.com
FYI - Phase 3 trial starting in Aug.2020 for Light Therapy (Photo Bio Modulation)
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