Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000147684
Ethics application status
Approved
Date submitted
2/02/2023
Date registered
14/02/2023
Date last updated
14/02/2023
Date data sharing statement initially provided
14/02/2023
Date results information initially provided
14/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
A ten-year study on the effects of strategic light exposure on the primary and secondary features of Parkinson's disease.
Scientific title
A ten-year study on the use of light treatment on the prodromal, motoric and psychiatric symptoms of Parkinson's disease.
Secondary ID [1] 308623 0
Bronowski Institute BIBN 02207
Universal Trial Number (UTN)
Trial acronym
LT10-PD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 328890 0
Condition category
Condition code
Neurological 325883 325883 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves exposure to polychromatic light (Light Therapy) emitted from a medical device specifically designed to treat the motor impairment, insomnia, fatigue, depression and anxiety of Parkinson’s disease. As is the case for treatment of other disorders with these symptoms (such as Seasonal Affective Disorder: SAD), patients will be treated for 1 hour per day with a measure amount of light at 3,000 to 5,000 LUX. Patients will be monitored and assessed during face-to-face consultations on a regularly scheduled basis. This is to ensure that the light is delivered to optimize phototransduction and to maximize the therapeutic effect. The duration of treatment will be for at least 2 months, up to 10 years. The treatment will be delivered and guided by a clinician with over 30 years of experience in treating sleep and psychiatric disorders using this methodology. The patient will be thoroughly briefed and monitored to ensure the light is delivered at the right time in the circadian cycle. The device will be used at home for an hour and ongoing device use will be monitored to ensure compliance. The Chief Investigator will be in contact with other health professionals to ensure treatment is compatible with other ongoing treatments. Treatments will be delivered daily at the critical time in the circadian cycle and patients will be monitored/assessed every week to week and a half.
Intervention code [1] 325342 0
Treatment: Devices
Comparator / control treatment
No control group per se is purposely employed as patients are part of an ongoing clinic. However, performance measures before the patient undergoes treatment is employed as the starting baseline and serves as the control measures. As it is the standard practice in the clinic, the efficacy of any treatment is achieved by making statistical comparisons with the baseline measures.
Control group
Active

Outcomes
Primary outcome [1] 333719 0
Primary Outcome 1: Change in the time to sleep and time to awaken as a result of 1 hour of light exposure. The instrument employed will be a sleep diary kept by the patient and by structured interview.
Timepoint [1] 333719 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced. Primary Timepoints: The Primary time points for this study are just prior to commencing treatment and then at each year for years 1 through 10.
Primary outcome [2] 333720 0
Primary Outcome 2: Change in sleep features including the total amount of sleep, the number of awakenings, and how readily the patient falls back to sleep as a result of 1 hour of light exposure. All sleep features will be analyzed together. The instrument employed will be a sleep diary kept by the patient and by structured interview.
Timepoint [2] 333720 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced. Primary Timepoints: The Primary time points for this study are just prior to commencing treatment and then at each year for years 1 through 10.
Primary outcome [3] 333721 0
Primary Outcome 3: Change in REM sleep behaviour disorder (RSBD) as a result of 1 hour of light exposure. The instrument employed will be a sleep diary kept by the patient and by structured interview.
Timepoint [3] 333721 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced. Primary Timepoints: The Primary time points for this study are just prior to commencing treatment and then at each year for years 1 through 10.
Secondary outcome [1] 418058 0
Secondary Outcome 1: Change in Fatigue as a result of 1 hour of light exposure. The instrument employed will be by structured interview and rated on a Likert scale rated in severity from 1 to 10 with 10 being the most severe.
Timepoint [1] 418058 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.
Secondary outcome [2] 418059 0
Secondary Outcome 2: Change in motor performance on the timed motor test (Elbow to fist) as a result of 1 hour of light exposure. The instrument employed will be by clinical assessment and will be timed and expressed in seconds.
Timepoint [2] 418059 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.
Secondary outcome [3] 418061 0
Secondary Outcome 3: Change in motor performance on the timed motor test (floor to knee) as a result of 1 hour of light exposure. The instrument employed will be by clinical assessment and will be timed and expressed in seconds.
Timepoint [3] 418061 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.
Secondary outcome [4] 418062 0
Secondary Outcome 4: Change in depression (affect) as a result of 1 hour of light exposure. The instrument employed will be by clinical assessment rated on a Likert scale rated in severity from 1 to 10 with 10 being the most severe.
Timepoint [4] 418062 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.
Secondary outcome [5] 418063 0
Secondary Outcome 5: Change in dyskinesia as a result of 1 hour of light exposure. The instrument employed will be by structured interview and rated on a Likert scale rated in severity from 1 to 10 with 10 being the most severe.
Timepoint [5] 418063 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.
Secondary outcome [6] 418064 0
Secondary Outcome 6: Change in Parkinsonian primary feature of Bradykinesia as a result of 1 hour of light exposure. The instrument employed will be by structured interview and rated on a Likert scale rated in severity from 1 to 10 with 10 being the most severe.
Timepoint [6] 418064 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.
Secondary outcome [7] 418065 0
Secondary Outcome 7: Change in anxiety as a result of 1 hour of light exposure. The instrument employed will be by structured interview and rated on a Likert scale rated in severity from 1 to 10 with 10 being the most severe.
Timepoint [7] 418065 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.
Secondary outcome [8] 418368 0
Secondary Outcome 6: Change in Parkinsonian primary feature of Rigidity as a result of 1 hour of light exposure. The instrument employed will be by structured interview and rated on a Likert scale rated in severity from 1 to 10 with 10 being the most severe.
Timepoint [8] 418368 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.
Secondary outcome [9] 418369 0
Secondary Outcome 6: Change in Parkinsonian primary feature of Tremor as a result of 1 hour of light exposure. The instrument employed will be by structured interview and rated on a Likert scale rated in severity from 1 to 10 with 10 being the most severe.
Timepoint [9] 418369 0
Timepoint: The time points for this study are just prior to commencing treatment and then at the following intervals of 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, then every 4 to 6 months thereafter, for as long as the patient remains in the program. The final assessment for the study will occur as close as is possible to 10 years, from the time treatment commenced.

Eligibility
Key inclusion criteria
Any patient diagnosed with Parkinson's disease by a qualified medical practitioner. Being an exploratory trial, we are examining the generalizability of any therapeutic effects to the general diagnosis of Parkinson's disease.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All patients are assigned to the treatment group when they enter the clinic.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As is standard operating procedure in the research clinic, statistical comparisons will be made at pre-selected time points at 1 month and 1,2,3,4,5,6,7 thru 10 years after entering the program, each compared to the baseline score. Using the same statistical approach as in previous work we first determine the suitability applying parametric analysis using an ANOVA for repeated measures. The data will be tested for homogeneity of variance and skewedness so as not to violate any assumptions of parametric testing. On this basis, if parametric analysis cannot be applied than non-parametric analysis will be employed. Due to the decreasing number of patients at each time point attributable to the natural attrition of patient numbers over such a long time period, a Related Samples Wilcoxon Signed Rank Test will be used comparing the baseline measurement before treatment with each time point thereafter. If multiple comparisons are employed then a Bonferroni correction will be applied. Tables and graphs will be constructed to accommodate the most meaningful expression of data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
10/01/2012
Date of last participant enrolment
Anticipated
Actual
15/06/2018
Date of last data collection
Anticipated
15/02/2023
Actual
Sample size
Target
114
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 39390 0
3442 - Woodend North

Funding & Sponsors
Funding source category [1] 312862 0
Charities/Societies/Foundations
Name [1] 312862 0
Dr Gregory L. Willis
Country [1] 312862 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Bronowski Institute of Behavioural Neuroscience
Address
40 Davy Street
Woodend, Vic 3442 Australia
Country
Australia
Secondary sponsor category [1] 314520 0
None
Name [1] 314520 0
N/A
Address [1] 314520 0
N/A
Country [1] 314520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312139 0
The Bronowski Institute Ethical Standards Committee (ESC)
Ethics committee address [1] 312139 0
40 Davy Street, Woodend VIC, Australia
Ethics committee country [1] 312139 0
Australia
Date submitted for ethics approval [1] 312139 0
01/12/2011
Approval date [1] 312139 0
14/12/2011
Ethics approval number [1] 312139 0
BRON-LT2-APRCONF-5-12-22

Summary
Brief summary
The involvement of the circadian system is becoming an increasingly important topic in respect to the aetiology and treatment of Parkinson’s disease (PD). PD is traditionally described as, a disorder predominantly of motor impairment, mediated by nigro-striatal DA (NSD) function. However, the secondary symptoms that proceed and accompany the disease during its course tell a different story. Insomnia, fatigue, depression and sleep disturbance are four of the most troublesome symptoms of PD that not only herald disease onset but also exacerbate primary symptoms and rob patients of their quality of life. Realigning circadian phase is the mechanism by which we can intervene in circadian function and phototherapy is the most effective method for doing so. Unfortunately, only a few studies have examined the efficacy of phototherapy as it relates to the protracted, ongoing nature of the disease itself. The present study examines the effect of light treatment for as long as ten years during the course of PD by monitoring primary and secondary symptoms at regular intervals. Improvement in circadian based symptoms observed including insomnia, fatigue, sleep architecture and depression may occur, and it is hypothesized that motor function will be subtle and occur incrementally. It is hypothesized that Improvement in both motor and secondary symptoms will occur for the duration of the study as long as patients used the treatment daily. The sequence of symptom recovery from secondary symptoms to motor impairment is expected to be slow suggesting that an incremental process of improvement is in tow, representing an inverse of the degenerative sequelae that continues over decades. Such a process would emulate the slow incremental process that characterizes the reparative process seen with pure disorders of circadian function. Recent findings suggesting that weakened circadian rhythmicity is associated with increased risk of PD thereby corroborating the possibility that “tweaking” the circadian system with a potent Zeitgeber may interfere with internal timing to slow the degenerative process of PD.
Trial website
Trial related presentations / publications
Public notes
N/A

Contacts
Principal investigator
Name 123618 0
Dr Gregory L. Willis
Address 123618 0
The Bronowski Institute of Behavioural Neuroscience
40 Davy Street
Woodend
Victoria 3442
Country 123618 0
Australia
Phone 123618 0
+61 4 11514980
Fax 123618 0
Email 123618 0
director@bronowski.org
Contact person for public queries
Name 123619 0
Miss Jane Holth
Address 123619 0
The Bronowski Institute of Behavioural Neuroscience
40 Davy street
Woodend, Victoria 3442
Country 123619 0
Australia
Phone 123619 0
+61 3 54271741
Fax 123619 0
Email 123619 0
PLO@bronowski.org
Contact person for scientific queries
Name 123620 0
Dr Greg Willis
Address 123620 0
The Bronowski Institute of Behavioural Neuroscience
40 Davy Street
Woodend
Victoria 3442
Country 123620 0
Australia
Phone 123620 0
+61411514980
Fax 123620 0
Email 123620 0
director@bronowski.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Raw data will be presented in formal publication.


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
No additional documents have been identified.