Efficacy Study of Light Therapy as an Adjunctive Treatment for Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT02175472|
Recruitment Status : Completed
First Posted : June 26, 2014
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Spectramax light therapy device Device: Control light device||Not Applicable|
Parkinson's disease (PD) is traditionally described as a disorder of compromised dopamine (DA) function in the nigro-striatal dopamine (NSD) system. This system extends from the midbrain, through the hypothalamus and into the forebrain to critical areas involved in the control of motor performance. Restoration of DA content in this system by administering the DA precursor L-dopa or DA agonists reinstates motor control, but provides only symptomatic relief with waning efficacy as the disease advances. Symptoms of depression and sleep disturbances are also commonly seen in PD patients, and the manifestation of these symptoms suggests impaired circadian function.
Although the involvement of the circadian system in PD was intimated in the first formal account of the disorder provided by James Parkinson, it was not until recently that circadian malfunction has been specifically cited as playing a major role in the development and progression of the disease. In addition to scattered reports depicting circadian-like features of PD and related syndromes, a large body of evidence describes the benefits of light therapy in PD from both the preclinical and clinical perspectives.
While the development of a formal understanding has been largely omitted as to the basis for any therapeutic effect exerted by light, recent studies have shown that the nigro-striatal dopamine system is comprised of the same cell type as cells in the retina and the pineal. Such cells are driven by visual input whereby dopamine and melatonin sit in functional opposition to regulate day night activities including sleep, mood, reproduction, anti-oxidation and movement. Hence one may conclude that the circadian system plays a major role in many aspects of PD.
Recent work in PD has also suggested that the efficacy of light therapy is mediated by melatonin and dopamine function in the retina. On this basis it would be reasonable to assume that intervention into the function of the circadian system with light therapy in PD patients might well serve to modify the course and consequences of the disease. The present study serves to extend this finding to the point of providing a practical, non-invasive method for helping patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Sixty Minute Exposure of Specific Bandwidth Light for the Treatment of Idiopathic Parkinson's Disease|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||December 23, 2016|
Active Comparator: Spectramax light therapy device
Light therapy device which emits a specific bandwidth combination and intensity of light.
Device: Spectramax light therapy device
Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.
Sham Comparator: Control light device
Light therapy device, identical in appearance and operation to the Spectramax device, except that it produces a different bandwidth and intensity, which is not believed to produce a therapeutic response.
Device: Control light device
The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
- Change in the Combined Scores (Sum) of Parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (M (MDS-UPDRS) From Baseline to Endpoint at 6 Months. [ Time Frame: Six Months ]
Part I: 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.
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.
Part III: Motor Examination: This portion of the scale assesses the motor signs of PD and is administered by the evaluator. There are 18 questions, however several questions have multiple parts which are also scored. Each question 0-4, Total range=0-132. Higher score=more severe
- Change in the Clinical Global Impression- Improvement Scale (CGI-I) From Baseline to Endpoint at 6 Months. [ Time Frame: Six months ]The Clinical Global Impression of Improvement is an assessment of the clinician's view of the patient's global functioning. Participants are ranked "O" at baseline. The CGI-I ranks 0 - 7, with "0" being much improved, "4" being neutral, and "7" being much worse.
- Change in the Score of the Parkinson's Disease Questionnaire - 39 From Baseline to Endpoint at 6 Months [ Time Frame: Six months ]
The 39 question Parkinson's Disease Questionnaire (PDQ-39) is a widely used patient reported rating scale 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
The questions are divided into eight measurement scales each comprising 3 to 10 questions. The scores for the questions in each scale are totaled and normalized to a scale of 0 - 100, that is equivalent to percent of maximum score. The scales are; Mobility (MOB): Q1-10; Activities of Daily Life (ADL): Q11-16; Emotional Well Being (EMO): Q17-22; Stigma (STI): Q23-26; Social Support (SOC): Q27-29; Cognitions (COG): Q30-33; Communication (COM) Q34-36; and Bodily Discomfort (BOD): Q37-39.
- Change in the Score of the Parkinson's Disease Sleep Scale-Disturbed Sleep, From Baseline to Endpoint at 6 Months. [ Time Frame: Six months ]The Parkinson's Disease Sleep Scale 2 (PDSS-2) is designed to assess nocturnal disability in Parkinson's disease. The PDSS-2 is a 15 question analog scale that ranks answers from 0 - 4, with 4 being worse. In addition to an overall assessment of sleep disability three aspects of sleep problems can be obtained; disturbed sleep (total of questions 1-3, 8 and 14), PD-specific nocturnal motor symptoms (total of questions 4-6, 12 and 13), and PD-specific nocturnal symptoms (Total of questions 7, 9-11 and 15). We selected the "Disturbed Sleep" subscale as a key secondary outcome measure. This subscale has a total range of 0 - 16, with 16 being more severe.
- Change in the Score of the Epworth Sleepiness Scale From Baseline to Endpoint at 6 Months. [ Time Frame: Six months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175472
|United States, Massachusetts|
|Massachusetts General Hospital (MGH)|
|Boston, Massachusetts, United States, 02114|
|United States, Utah|
|Aspen Clinical Research|
|Orem, Utah, United States, 84058|
|VU University Medical Center (VUmc)|
|Amsterdam, MB, Netherlands, 1007|
|Study Director:||Dan Adams||PhotoPharmics, Inc.|