DB RCT for Specialized Phototherapy in Parkinson's Disease.

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.

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.

The Parkinson's Disease Health Index (PD-HI) is a highly sensitive disease specific patient response outcome measure, designed to measure the longitudinal progression of Parkinson's disease and treatment effectiveness. The PD-HI combines 13 sub-domains according to the prevalence and impact of Parkinson's symptoms on patients. Each domain is ranked by the individual on a Likert scale of 0-100, according to how the domain is currently affecting them. A higher score reflects a more severe condition. An algorithm is used to compute the total score, with 100 being the highest score possible. The PD-HI will be used at Baseline, at Week 13, and at Week 26.

The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness to help in diagnosing sleep disorders. The ESS questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 (none) to 3 (worse) for eight different everyday situations. The total range is 0 - 24, with higher scores representing worse severity.

The SCOPA-SLEEP is a frequency measure scale to assess the character and quantify the various aspects of sleep problems in Parkinson's disease. The SCOPA-Sleep consists of 13 items, including information about the use of sleeping tablets. Questions range from 0 to 4 in severity, (Question 7, Quality of Sleep, ranges from 0-7). A higher total score indicates more severe sleep problems.

The Beck Depression Inventory (BDI) is a 21-question multiple choice inventory to measure the severity of depression. Each question is scored on a scale value of 0 to 3. The cutoffs used are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.

The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). Input from a caregiver to the participant is acceptable.

The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA will be used at screening, mainly for characterization purposes and to assist the site investigators in their decisions to include participants in the trial. Higher scores indicate better cognitive function, while a score below 26 may indicate mild cognitive impairment. The MoCA will be assessed at baseline, Week 13, and Week 26.

The MDS-UPDRS Part 3 is the motor examination section of the MDS-UPDRS. It is completed by the Evaluator. Part 3 evaluates speech, tremor, bradykinesia, rigidity, spontaneity of movement, gait, and balance. Because rigidity (3.3) and postural stability (3.12) cannot be measured remotely, a modified version, which omits these questions will be used. The same rater will evaluate the same participants whenever possible, and at the same time of day. Raters must be certified in the use of the MDS-UPDRS.

The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. The instrument comprises a short descriptive system questionnaire covering five areas which assess quality of life issues, and a visual analogue scale (EQ VAS) that provides a simple descriptive profile of a respondent's health state. The 5L refers to five levels (0-4) of increasing severity for each question.

The Parkinson's Disease Patient Report of Problems is an online assessment tool that allows patients to describe their most bothersome problems and how these problems affect their daily functioning in their own terms. The tool then uses algorithms and machine learning to quantify those problems and their progression with greater sensitivity and detail that is unavailable from other assessments. The PD-PROP classifies these answers into a total of 56 clinically meaningful symptoms, representing four motor and six non-motor domains. The PD PROP will be assessed at baseline, Week 13, and Week 26.