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Trial registered on ANZCTR


Registration number
ACTRN12617001309370
Ethics application status
Approved
Date submitted
28/08/2017
Date registered
12/09/2017
Date last updated
14/01/2019
Date data sharing statement initially provided
14/01/2019
Date results information initially provided
14/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Use of Bright Light Therapy in the Treatment of Parkinson's Disease
Scientific title
A Randomised, Double-Blind, Placebo controlled Trial Using Strategic Light exposure in the Treatment of Parkinson's Disease
Secondary ID [1] 292770 0
Nil
Universal Trial Number (UTN)
U1111-1201-3606
Trial acronym
The SLIPD Study
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 304541 0
Insomnia 304545 0
Condition category
Condition code
Neurological 303864 303864 0 0
Parkinson's disease
Mental Health 303865 303865 0 0
Other mental health disorders
Mental Health 303866 303866 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention employed in the SLIPD Study involved a modification of light therapy that had been employed in the clinic for a time ranging from 4 months to 5 years for patients attending the Bronowski Clinic. The fluorescent, polychromatic light source employed is an Apollo BL6 designed for the treatment of seasonal affective disorder (SAD). In patients already using the BL6 there were 3 groups employed in the study. the first is the active group that were supplied at the beginning of the trial with a slightly opaque, clear filter that only slightly decreased the total emission from the source by about 15% (otherwise the emission spectra remained the same, n=10). The second group received a filter that permitted the emission of only primary red (Lee Filters # 106) at the beginning of the study (n-10). The filters were fitted onto the light sources that had been in use by each patient prior to commencing the study. The light was situated approximately 1.0 metres from the patient which delivered approximately 3-4000 LUX of polychromatic light for 1 hour per night just prior to retiring. The procedure was the same as that occurring prior to the trial with the exception that a filter was applied after the first assessment on day 1 of the trial. To insure treatment compliance, the criterion of at least 4 months of program participation was chosen as such patients with such experience routinely exhibit long term commitment. In addition, patients are evaluated during each time point during the course of the trials in the presence of a carer, spouse, relative or partner to evaluate the level of compliance achieved. The trial lasted a total of 2 weeks with assessments made 1 and 2 weeks after commencing the trial.. Dr. Willis was the clinician instructing and monitoring and assessing the patients during the course of the trial. Dr. Willis has had more than 25 years experience in assessing PD patients and in the application of light treatment for neuropsychiatric disorders.
Intervention code [1] 298989 0
Treatment: Devices
Comparator / control treatment
As a control group 10 patients that had been maintained on light therapy as an adjunct to their routine PD treatment for a period of 4 months to 5 years were instructed to discontinue their treatment for a period of 2 weeks for the duration of the study. This was termed a "reverse control" in the sense that all patients in the study reported advantageous effects of light prior to commencing the trial. This paradigm was instituted in the present trial to control for technical problems that develop in trials that have employed de novo patients requiring 3-4 months of adjustment before they apply the light properly during each daily exposure.
Control group
Active

Outcomes
Primary outcome [1] 303219 0
The primary endpoint will be a change in the total Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDSUPDRS)
Timepoint [1] 303219 0
The primary time points will be at Week 1 and week 2 after baseline measurement
Primary outcome [2] 303220 0
The 2nd primary endpoint will be a change in the total PDQ39 score
Timepoint [2] 303220 0
The primary time points will be at week 1 and week 2 after baseline measurement
Primary outcome [3] 303221 0
The 3nd primary endpoint will be a change in the total Beck Depression Inventory2 score
Timepoint [3] 303221 0
The primary time points will be at Week 1 and week 2 after baseline measurement
Secondary outcome [1] 338269 0
The secondary endpoint will be a change in the total Epworth Sleep Scale score.
Timepoint [1] 338269 0
The secondary endpoints will be measured at week 1 and week 2 after baseline measurment
Secondary outcome [2] 338271 0
The secondary endpoint will be a change in the total Brief Bronowski Scale Scale score. This scale provides a global rating for Parkinsonian Symptoms plus the timing of 2 motor tests involving standardized arm and leg movement.
Timepoint [2] 338271 0
The secondary endpoint will occur at week 1 and 2 after baseline measurement.

Eligibility
Key inclusion criteria
A. Inclusion in the Bronowski Clinic Program for at least 4 months
B. Idiopathic Parkinson's disease
C. Receiving dopamine (DA) Replacement for at least 12 months

Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Less than 12 months of responsive dopamine replacement therapy
2. Participation in a study of investigational or marketed drugs or devices during the 30-day period prior to the start of the study or during the study
3. Subjects who are medically complicated, medically unstable and/or have other severe co-morbid disease states, as determined by the investigator.
4. History of concurrent psychiatric illness that would preclude compliance with the protocol and/or ability to complete the study safely
5. History or current diagnosis of major psychiatric disorder including Bipolar I Disorder that could interfere with accurate assessment and effective treatment.
6. History of current or recent (within previous 12 months) alcohol, narcotic or other drug abuse by DSM-IV criteria
7. Active suicidal or homicidal ideation or plan, as determined by the attending clinician.
8. Use of light therapy treatment less than 4 months
9. Females of childbearing age
10. Currently working night shift
11. Planned travel outside of the state in which the trial is being conducted
12. Current use or use within the previous 1 month of photosensitizing or other medications including amiodarone, benoxaprofen, chlorpromazine, demeclocycline, fleroxacin, nalidixic acid, ofloxacin, piroxicam, porfimer, psoralens, quinidine, temoporfin tetracycline or oral isoretinoin (Accutane) or other remedies (St. John’s wort, melatonin)
13. History of significant eye trauma or disease, retinopathy, and/or cataract of a level that would significantly affect transmission or processing of light through either eye
14. Other neurological disorders
15. Pre-existing major joint problems
16. Any history of cerebral insult or central nervous system infection
17. Cognitive impairment as determined by the attending clinician.
18. Focal neurological deficits
19. Severe dyskinaesia attributable to dopamine replacement therapy or high TDB.


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Block randomization was achieved by the method of sealed envelope. All permutations and combinations of the 3 groups were randomly selected : (1,2,3; 1,3,2; 2,1,3; 2,3,1; 3,2,1; 3;1;2) . Each patients was assigned to each group as they entered the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was random as patients were assigned to each block as they formally signed up for the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
While there were two groups implemented in the study that used light, those assigned to the group using the red filter were not aware that the red filter fitted to the device was the same as the group where no light was being used. Also all parties using either the clear filter (the active) and the red filter were instructed at the commencement of the study that each would be using a device fitted with a filter that would alter the emission. Neither was aware of whether or not their filter would work. This controlled for the expectation of a better or worse outcome.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The number of patients was chosen on the basis of results obtained from an open label study undertaken in 2012 by Willis et al, involving 159 patients and published in a refereed journal.. While power calculations were attempted on the basis of that work, the number of patients involved was limited by the numbers available at the Bronowski Clinic as many of the patients attending the clinic came from distances that would preclude them from attending 3 times in 2 weeks. The cost and health problems were taken into account in this regard. After preliminary assessment with parametric states violations of the assumptions of parametric statistics required movement to non-parametrics including Friedman's Two-way ANOVA and The Wicoxian Signed Rank Test as the primary forms of analysis. .

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8969 0
The Bronowski Institute of Behavioural Neuroscience - Woodend
Recruitment postcode(s) [1] 17466 0
3442 - Woodend North

Funding & Sponsors
Funding source category [1] 297390 0
Other
Name [1] 297390 0
The Bronowski Institute of Behavioural Neuroscience Inc
Address [1] 297390 0
40 Davy Street
Woodend, Vic 3442
Country [1] 297390 0
Australia
Primary sponsor type
Other
Name
The Bronowski Institute of Behavioural Neuroscience Inc
Address
40 Davy Street
Woodend, Vic.
3442
Country
Australia
Secondary sponsor category [1] 296377 0
None
Name [1] 296377 0
Address [1] 296377 0
Country [1] 296377 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298489 0
Swan Research Institute Human Research Ethics Committee
Ethics committee address [1] 298489 0
300 Mangrove Creek Road
Mangrove Creek, N.S.W. 7250

Ethics committee country [1] 298489 0
Australia
Date submitted for ethics approval [1] 298489 0
17/10/2013
Approval date [1] 298489 0
14/02/2014
Ethics approval number [1] 298489 0
BRONAU-2012-2

Summary
Brief summary
This study evaluated the efficacy of specific bandwidth phototherapy as an adjunctive treatment for the treatment of Parkinson’s disease. This study examined a non-invasive non-significant risk device to be used in combination with ongoing pharmacotherapy for Parkinson’s disease, in Parkinson’s patients already undergoing light therapy using broad spectrum, polychromatic light. While light treatment has been found to be effective in treating various forms of Parkinsonian symptoms it was originally employed to determine if it might be effective in treating comorbid symptoms of depression and insomnia associated with Parkinson’s disease. In several preclinical and clinical studies to date, not only has it been found that light therapy improves these parameters but the primary symptoms of bradykinaesia, rigidity, tremor and nocturnal myoclonus improved as well [Willis and Turner, Chronobiology International, 2007; Willis et al, Reviews in the Neurosciences, 2012; Rutten et al, Parkinson's Disorders, 2012; Videnovic et al, Movement. Disorders, 2017]. However, with continuing work on this theme the parameters surrounding the use of phototherapy have become better defined as to the frequency, time and duration of light use, the concomitant use of drugs and the management of physiological function so as to define the most effective treatment strategy for use in a double blind, placebo controlled trial. A preliminary blind trail has been undertaken which reports significant improvement in various Parkinsonian parameters (Paus et al, Movement. Disorders. 2007) and the present study implemented a more effective treatment regimen in a controlled design.
Trial website
Trial related presentations / publications
none
Public notes
This SRI Committee was, in fact, a registered NH&MRC committee prior to and for the duration of the present study. At the completion of the study the Director of the SRI, Philip Stevens, joined the Department of Medicine at Monash University and the Ethics Committee was no longer operational as of August 2015, I was informed on August 12th, 2015 that the remaining post-trial ethical issues in regard to our study would be dealt with by the NH&MRC directly. The main issues of concern were storage of trial data, data access and destruction of data at 5 years after formal publication. While we will be accessing the relevant NH&MRC resources when required, the Ethical Standards Committee (SRC) of the Bronowski Institute will be monitoring our activity regarding these issues. Please note the Bronowski SRC is an advisory committee for the general ethical issues confronting the Bronowski Institute and not a bona fide HREC per se.
Attachments [1] 3140 3140 0 0

Contacts
Principal investigator
Name 77250 0
Dr Gregory L. Willis
Address 77250 0
The Bronowski Clinic
40 Davy street
Woodend, Vic 3442
The Bronowski Institute of Behavioural Neuroscience
Coliban Medical Centre, 19 Jennings Street, Kyneton, Vic 3444
Country 77250 0
Australia
Phone 77250 0
+61 411514980
Fax 77250 0
+61 3 54 271 494
Email 77250 0
director@bronowski.org
Contact person for public queries
Name 77251 0
Mrs Jane Holth
Address 77251 0
Public Liaison Officer
The Bronowski Institute of Behavioural Neuroscience
Coliban Medical Centre
19 Jennings Street
Kyneton, Vic 3444
Country 77251 0
Australia
Phone 77251 0
+61 3 54 271741
Fax 77251 0
N/A
Email 77251 0
plo@bronowski.org
Contact person for scientific queries
Name 77252 0
Dr Gregory L. Willis
Address 77252 0
Coliban Medical Centre
19 Jennings Street
Woodend, Vic 3442
Country 77252 0
Australia
Phone 77252 0
+61 411514980
Fax 77252 0
N/A
Email 77252 0
director@bronowski.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary