- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04453033
DB RCT for Specialized Phototherapy in Parkinson's Disease. (LIGHT-PD)
Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dan Adams
- Phone Number: 8014947804
- Email: dan.adams@photopharmics.com
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- Recruiting
- University of Rochester
-
Contact:
- Christi ALessi-Fox, M.S.
- Phone Number: 585-275-3507
- Email: christi.alessi-fox@chet.rochester.edu
-
Contact:
- Karen Clark, BS
- Phone Number: 585-275-3507
- Email: karen.clark@chet.rochester.edu
-
Principal Investigator:
- Jamie Adams, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
It is impossible to tell the difference between the sham device and the active device by looking at them.
|
Ocular phototherapy light panel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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. |
26 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
26 weeks
|
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.
|
26 weeks
|
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.
|
26 weeks
|
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.
|
26 weeks
|
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
|
26 weeks
|
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.
|
26 weeks
|
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).
|
26 weeks
|
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.
|
26 weeks
|
Parkinson's Disease Health Index (PD-HI)
Time Frame: 26 weeks
|
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.
|
26 weeks
|
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.
The MoCA will be assessed at baseline, Week 13, and Week 26.
|
26 weeks
|
Parkinson's Disease Patient Report of Problems (PD PROP)
Time Frame: 26 Weeks
|
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.
|
26 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ray Dorsey, MD, University of Rochester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT-2401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Parkinson Disease
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedParkinson Disease 6, Early-Onset | Parkinson Disease (Autosomal Recessive, Early Onset) 7, Human | Parkinson Disease Autosomal Recessive, Early Onset | Parkinson Disease, Autosomal Recessive Early-Onset, Digenic, Pink1/Dj1United States
-
ProgenaBiomeRecruitingParkinson Disease | Parkinsons Disease With Dementia | Parkinson-Dementia Syndrome | Parkinson Disease 2 | Parkinson Disease 3 | Parkinson Disease 4United States
-
King's College LondonGlaxoSmithKlineCompletedParkinson Disease | Idiopathic Parkinson Disease | Parkinson Disease, PARK8United Kingdom
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
National Yang Ming UniversityUnknownEarly Onset Parkinson Disease | Early Stage Parkinson Disease
-
Michele Tagliati, MDRecruitingREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Cedars-Sinai Medical CenterEnrolling by invitationREM Sleep Behavior Disorder | Symptomatic Parkinson Disease | Pre-motor Parkinson DiseaseUnited States
-
Mahatma Gandhi Institute of Medical SciencesCompletedStroke, Parkinson' s Disease, Neurological Impairments, Tele-rehabilitationIndia
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
University of DeustoCompletedPARKINSON DISEASE (Disorder)Spain
Clinical Trials on Celeste Specialized Phototherapy Device
-
University of ArizonaCeraZ LLCRecruiting
-
Nathalie CharpakHospital Universitario San Ignacio; Pontificia Universidad JaverianaCompletedPhototherapy | Jaundice, NeonatalColombia
-
Maculume Ltd.Completed
-
University Hospital, LilleInstitut National de la Santé Et de la Recherche Médicale, FranceRecruitingNeonatal JaundiceFrance
-
Tri-Service General HospitalUnknown
-
Hermano Miguel FoundationCompletedSprains and Strains | Tendinopathy | Fasciitis | Epicondylitis | Muscle SpasmEcuador
-
Bryan TompsonCompletedThe Rate or Orthodontic Tooth MovementCanada
-
Istituto Nazionale di Ricovero e Cura per AnzianiEuropean UnionActive, not recruitingQuality of Life | Older AdultsItaly, France, Germany, Japan
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedMuscle Development in Association to PhototherapyBrazil