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
Last Update Posted : April 17, 2017
|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 of parts I, II, and III of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) from baseline to endpoint [ 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.
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.
Part III: Motor Examination: This portion of the scale assesses the motor signs of PD and is administered by the evaluator
- Change in the Total Score of MDS-UPDRS from Baseline to Endpoint [ Time Frame: Six months ]The Unified Parkinson's Disease Rating Scale has four parts; Part I (non-motor experiences of daily living), Part II (motor experiences of daily living, Part III (motor examination) and Part IV (motor complications). All 4 parts will be completed and a total score will be calculated.
- Change in the score of the Beck Depression Inventory II from baseline to endpoint [ Time Frame: Six months ]Patients will answer a 21-question, multiple-choice inventory for measuring the severity of depression. There is a 4-point score for each question ranging from 0 to 3. The score for each of the 21 questions is summed to give a single score for the BDI-II.
- Change in the score of the Beck Anxiety Inventory from baseline to endpoint [ Time Frame: Six months ]Patients will indicate how much they have been bothered by common symptoms of anxiety during the past month (including the day of the evaluation) by circling a number from 0-3 next to each symptom. The sum of the circled numbers is the score for the Beck Anxiety Inventory.
- Change in the score of the Parkinson's disease Sleep Scale - 2, from baseline to endpoint [ Time Frame: Six months ]Patients will rate the severity of common sleep experiences during the past week (7 days), by indicating a number from 0-4 next to each experience. The sum of the indicated numbers is the score for the Parkinson's Disease Sleep Scale - 2
- Change in the score of the Epworth Sleepiness Scale from baseline to endpoint [ Time Frame: Six months ]Patients will evaluate a list of eight situations in which they rate their tendency to become sleepy by indicating a number from 0-3. The sum of these numbers is the score for the Epworth Sleepiness Scale.
- Change in the score of the Parkinson's Disease Questionnaire 39 from baseline to endpoint [ Time Frame: Six months ]Patients will answer 39 questions regarding how often during the last month PD has affected various items by checking "Never", "Occasionally", "Sometimes", "Often", "Always (or cannot do at all)". These answers will be transformed into numbers from 0-4 and the sum of these numbers for each subpart and the overall sum are the scores for the Parkinson's Disease Questionnaire 39.
- Change in the score of the Wearing Off - Quick 10 Questionnaire from baseline to endpoint [ Time Frame: Six months ]Patients will identify any of 10 listed symptoms they currently experience during a normal day and whether each identified symptom usually improves or disappears after they take their dose of Parkinson's medication. The number of symptoms experienced will be totaled, and the number of symptoms that improve or disappear will be totaled. Patients will also report their impression of improvement on a scale of 0-4 (0: "very much worse", 1: "much worse", 2: "no change", 3: "much improved", and 4: "very much improved").
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|