ANZCTR - Registration

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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

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]

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

Insomnia

Condition category

Condition code

Neurological

Parkinson's disease

Mental Health

Other mental health disorders

Mental Health

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]

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]

The primary endpoint will be a change in the total Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDSUPDRS)

Timepoint [1]

The primary time points will be at Week 1 and week 2 after baseline measurement

Primary outcome [2]

The 2nd primary endpoint will be a change in the total PDQ39 score

Timepoint [2]

The primary time points will be at week 1 and week 2 after baseline measurement

Primary outcome [3]

The 3nd primary endpoint will be a change in the total Beck Depression Inventory2 score

Timepoint [3]

The primary time points will be at Week 1 and week 2 after baseline measurement

Secondary outcome [1]

The secondary endpoint will be a change in the total Epworth Sleep Scale score.

Timepoint [1]

The secondary endpoints will be measured at week 1 and week 2 after baseline measurment

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

9/07/2014

Date of last participant enrolment

Anticipated

Actual

29/01/2015

Date of last data collection

Anticipated

Actual

12/02/2015

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Bronowski Institute of Behavioural Neuroscience - Woodend

Recruitment postcode(s) [1]

3442 - Woodend North

Funding & Sponsors

Funding source category [1]

Other

Name [1]

The Bronowski Institute of Behavioural Neuroscience Inc

Address [1]

40 Davy Street
Woodend, Vic 3442

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Swan Research Institute Human Research Ethics Committee

Ethics committee address [1]

300 Mangrove Creek Road
Mangrove Creek, N.S.W. 7250

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/10/2013

Approval date [1]

14/02/2014

Ethics approval number [1]

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]

/AnzctrAttachments/373548-FRONTIERS PUBLICATION 2018.pdf (Publication)

Contacts

Principal investigator

Name

Dr Gregory L. Willis

Address

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

Australia

Phone

+61 411514980

Fax

+61 3 54 271 494

director@bronowski.org

Contact person for public queries

Name

Jane Holth

Address

Public Liaison Officer
The Bronowski Institute of Behavioural Neuroscience
Coliban Medical Centre
19 Jennings Street
Kyneton, Vic 3444

Country

Australia

Phone

+61 3 54 271741

Fax

N/A

plo@bronowski.org

Contact person for scientific queries

Name

Gregory L. Willis

Address

Coliban Medical Centre
19 Jennings Street
Woodend, Vic 3442

Country

Australia

Phone

+61 411514980

Fax

N/A

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?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Polychromatic light exposure as a therapeutic in the treatment and management of Parkinson's disease: A controlled exploratory trial.	2018	https://dx.doi.org/10.3389/fneur.2018.00741

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added automatically