DB RCT for Specialized Phototherapy in Parkinson's Disease. (LIGHT-PD)
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|ClinicalTrials.gov Identifier: NCT04453033|
Recruitment Status : Not yet recruiting
First Posted : July 1, 2020
Last Update Posted : September 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Celeste Specialized Phototherapy Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The purpose of the study is to determine whether one intensity is more effective than other intensities of light, and it is unknown whether one intensity will be more effective. Thus, subjects will receive a study device which looks identical to the other devices and which produces the same bandwidths (color), but which may produce a different intensity of that color of light. 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. A separate Medical Monitor may become unmasked if the participants experience a serious adverse event that may be related to the therapy. However, this is unlikely, since the therapy is considered safe.|
|Official Title:||Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.|
|Estimated Study Start Date :||December 2022|
|Estimated Primary Completion Date :||July 2024|
|Estimated Study Completion Date :||November 2024|
Active Comparator: Investigational Device
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
Ocular phototherapy light panel
Sham Comparator: Control Device
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.
Device: Celeste Specialized Phototherapy Device
Ocular phototherapy light panel
- Parkinson's Disease Questionnaire-39 (PDQ-39) [ Time Frame: 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.
- Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2 [ Time Frame: 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.
- Epworth Sleepiness Scale (ESS) [ Time Frame: 26 weeks ]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.
- Beck Depression Inventory -II (BDI-II) [ Time Frame: 26 weeks ]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.
- Beck Anxiety Scale (BAI) [ Time Frame: 26 weeks ]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.
- Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep) [ Time Frame: 26 weeks ]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.
- Cogstate Brief Battery (CBB) [ Time Frame: 26 weeks ]The CogState Brief Battery (CBB) is a brief, computer-administered cognitive test battery that consists of four cognitive tasks that measure psychomotor function, attention, working memory and memory. The administration, scoring and reporting is automated and highly standardized. Each task in the battery is constructed using playing cards as stimuli with the test taker required to answer only "yes" or "no" on each trial in accord with a simple rule. A higher score indicates better cognition. The CBB will be used at Baseline and again at Week 26. An efficacy analysis may be conducted at the end of the study.
- Fatigue Severity Scale (FSS) [ Time Frame: 26 weeks ]The Fatigue Severity Scale is a 9-item, self-report scale, which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Answers are scored on a seven-point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer
- Montreal Cognitive Assessment (MoCA) [ Time Frame: 26 weeks ]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.
- Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 (Modified) [ Time Frame: 26 weeks ]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.
- Movement Disorders Society Unified Parkinson's Disease Rating Scale, Part 4 (MDS-UPDRS 4) [ Time Frame: 26 weeks ]The MDS-UPDRS Part 4 assesses motor complications the person with Parkinson's has experienced over the past week. Part 4 covers time of the waking day spent with dyskinesias, and impact of dyskinesias. It also assesses motor fluctuations, including: Time spent in OFF state, functional impact of fluctuations, predictability of OFF episodes, and painful OFF state dystonia. Scores in each category are rated from "0" (normal) to "4" (severe).
- EuroQol-5 Dimensions (EQ-5D-5L) [ Time Frame: 26 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453033
|Contact: Dan Adamsfirstname.lastname@example.org|
|Principal Investigator:||Ray Dorsey, MD||University of Rochester|