Parkinson Disease
Conditions
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.
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 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.
Interventions
DEVICECeleste Specialized Phototherapy Device
Ocular phototherapy light panel
Sponsors
PhotoPharmics, Inc.
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Research suggests that certain wavelengths of light are more effective in treating Parkinson's, which means this therapeutic light device does not need to be nearly as bright as traditional light therapy. This study will test a light therapy device (Celeste® specialized light therapy device). We are testing two devices in this study: an active device which has these special wavelengths, and a control device which does not have the special wavelengths. Both lights look the same, and it is not possible to tell which light has the effective wavelength by looking at it. No one involved in the study (patients, families, doctors, investigative staff) knows which type of light therapy each person receives. A Device Technician, separate from the trial, will assist the participants in the device setup. Participants will be instructed not to disclose any aspects of their device. All study staff will be masked.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parkinson's Disease Questionnaire-39 (PDQ-39) | 26 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2 | 26 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRay Dorsey, MD
University of Rochester
Outcome results
None listed