ANZCTR - Registration

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

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]

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

Condition category

Condition code

Neurological

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

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]

3442 - Woodend North

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Dr Gregory L. Willis

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

The Bronowski Institute of Behavioural Neuroscience

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Bronowski Institute Ethical Standards Committee (ESC)

Ethics committee address [1]

40 Davy Street, Woodend VIC, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/12/2011

Approval date [1]

14/12/2011

Ethics approval number [1]

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

Public notes

N/A

Contacts

Principal investigator

Name

Dr Gregory L. Willis

Address

The Bronowski Institute of Behavioural Neuroscience
40 Davy Street
Woodend
Victoria 3442

Country

Australia

Phone

+61 4 11514980

Email

director@bronowski.org

Contact person for public queries

Name

Jane Holth

Address

The Bronowski Institute of Behavioural Neuroscience
40 Davy street
Woodend, Victoria 3442

Country

Australia

Phone

+61 3 54271741

Email

PLO@bronowski.org

Contact person for scientific queries

Name

Greg Willis

Address

The Bronowski Institute of Behavioural Neuroscience
40 Davy Street
Woodend
Victoria 3442

Country

Australia

Phone

+61411514980

Email

director@bronowski.org

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