DB RCT for Specialized Phototherapy in Parkinson's Disease.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 the Parkinson's Disease Questionnaire-39 Summary Index (PDQ-39SI). The PDQ-39 is a patient-reported, quality of life scale. The key secondary endpoint 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.

Official Title
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Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Celeste Specialized Phototherapy Device


Participation Criteria
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Eligibility Criteria
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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 Significant OFF state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study. 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 -

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a six-month, randomized, double-blind, controlled, parallel group study with visits at screening, baseline, weeks 13 and 26, and blinded coordinator calls throughout the study for safety and efficacy assessments. This study will use a remote trial design, which will allow participants to be recruited nationally and evaluated centrally using video conferencing. All study participants will have their eligibility assessed and confirmed by a study coordinator and a PD specialist (primary investigator). Participants will complete the secondary outcome measures, which are Patient Response Outcomes (PRO's), and will be assisted by a blinded coordinator to ensure completeness of answers. A blinded rater will conduct the Primary Outcome Measure as well as the MDS-UPDRS. All assessments will be conducted by video at Baseline, Week 13, and Week 26 visits.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Investigational Device<br>The Celeste device resembles a large tablet. It has a protective cover that folds into a stand and is magnetically attached to the back of the device. It produces a low intensity of specific bandwidths of light believed to be responsible for circadian and alerting responses in humans. The overall emission produces a pleasing soft glow of light. | Device: Celeste Specialized Phototherapy Device<br>* Ocular phototherapy light panel<br>|
| Sham Comparator: Control Device<br>The Control device is identical in appearance to Celeste. When turned on, the device emits a soft diffused light that is indistinguishable in color from the Active Device. However, this device produces a different amount of the specific wavelengths thought to be effective in the Active Device. It is impossible to tell the difference between the sham device and the active device by looking at them. | Device: Celeste Specialized Phototherapy Device<br>* Ocular phototherapy light panel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinson's Disease Questionnaire-39 (PDQ-39) | The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported rating scale for quality of life in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156, with higher scores representing worse severity. | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2 | MDS-UPDRS Part 1: Non-motor impact of experiences of daily living. Part I has 13 questions, the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65, with higher scores representing worse severity. MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire. Each question = 0-4, range = 0-65. with higher scores representing worse severity. | 26 weeks |