DB RCT for Specialized Phototherapy in Parkinson's Disease.

PhotoPharmics, Inc.350 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

350

Conditions

Parkinson Disease

Interventions

Celeste Specialized Phototherapy DeviceDEVICE

Ocular phototherapy light panel

Eligibility

Sex: ALLMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 26 weeks

Secondary Outcomes

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.

Time frame: 26 weeks

Data from ClinicalTrials.gov

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