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Trial registered on ANZCTR


Registration number
ACTRN12618000038291p
Ethics application status
Submitted, not yet approved
Date submitted
15/11/2017
Date registered
12/01/2018
Date last updated
12/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does light therapy affect quality of life and movement in people with Parkinson's Disease?
Scientific title
Evaluation of dose of Photobiomodulation (Light) Therapy and Physiotherapy for Improving Quality of Life Outcomes and Mobility in Parkinson’s Disease (Pilot).
Secondary ID [1] 293442 0
Nil known
Universal Trial Number (UTN)
U1111-1205-2035
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 305492 0
Condition category
Condition code
Neurological 304744 304744 0 0
Neurodegenerative diseases
Neurological 304745 304745 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Photobiomodulation therapy (PBMt)
All participants will receive usual care physiotherapy regardless of the PBMt intervention.

Description: Photobiomodulation Therapy (PBMt) which is a type of medical light therapy has positive effects on nerve cells in a range of neurological conditions, including Parkinson’s Disease (PD). We also know that this medical light therapy is safe with no side effects. Recent, clinical studies have shown that PBMt has positive effects in some complex neurological conditions including stroke and traumatic brain injury in humans. There have also been some very promising early results for the treatment of PD reported in animal models. Finally, recently there have been a few patients that have trialled their own “home made” systems of medical light therapy with PD (The Australian Magazine, October 8th 2017) and reported good symptomatic responses. Unfortunately, the science about how much dose to give, for how long, what form of light therapy produces positive results and which symptoms are mostly affected if any, are not known yet. This research project hopes to answer a few of these questions.

PBMt doses will be delivered individually to eligible participants in a clinic setting by qualified physiotherapists to various parts of the body and slowly increased each four weeks - there will be three dose variations evaluated. We plan to measure the effects of the treatments in two ways throughout this period:
a) at home by weekly observations made by a reliable person who lives with you, and
b) in the clinical setting with specialist and physiotherapy evaluations.

There will be two different forms of medical light trialled with the participant with Parkinson’s Disease:
a) one that could eventually be recommended for home use (commercially available as the “VieLight Neuro” device and to be used only in the Brisbane arm of the trial), and
b) one that is a clinic based therapy (commercially available as the Irradia Mid-Laser 2.5 device and will be used in both the Brisbane and Sydney arms of the trial).
In this study, the medical light will be applied by a trained physiotherapist, and the type of light will have been randomly allocated if the participant is in the Brisbane arm of the trial.
The VieLight device consists of a number of light emitting diodes of 810nm wavelength attached to a frame that fits over the user’s head. Further information about this device is available at: http://vielight.com/neuro-alpha-gamma/ . Further information regarding the Irradia Mid-Laser 2.5 is available at: http://www.irradia-australia.com.au/mid-25/ .
The VieLight will be used for the Brisbane A arm of the trial for a standard treatment time of 20 minutes with application points at the base of the skull, crown of the head, forehead, left and right temples, and the nostril. The Irradia device will be used for the Brisbane B arm of the trial and applied for approximately 10 minutes utilising the 4 diode cluster probe (904nm) to the same positions on the head as for the VieLight device. Brisbane participants will be randomised to either Brisbane A or Brisbane B. Depending on the participant’s circumstances, it may be possible to undertake the PBM therapy in the home setting.
In the Sydney arm of the trial, only the Irradia device described above will be used. That is, there is no randomisation to alternative forms of PBM therapy. PBM will be applied to the front and back of the neck (9 points), the upper part of the back (9 points) and the abdominal region (8 points) making a total of 26 application points. Total delivery time will be 15 minutes. In the Sydney arm of the trial, it will not be possible to undertake the PBM therapy in the home setting. All treatments will occur at the trial site.

The total energy density per diode for either device will be 60 J/cm2. Dose escalation will occur for every participant, every 4 weeks simply by increasing the number of visitations. That is, for the first 4 weeks of PBM therapy, participants will have PBM therapy once a week. For the second 4-week block, participants will have PBM therapy twice per week. For the final four week period, participants will have PBM therapy 3 times / week. Over the 10 months of the trial, therefore, participants will be seen 7 times for physiotherapy + 24 times for PBMt. Physiotherapy will be timed with PBM therapy when possible. PBM therapy will commence 2 weeks after physiotherapy intervention has commenced in order to allow changes to occur that might be attributable to physiotherapy.
The order of visitations is as follows:
Appointment 1) Attend physiotherapy assessment and initial intervention at the trial sites (physiotherapy clinics in Brisbane and Sydney). Then physiotherapy appointments subsequently each fortnight for 1 month, each month for 3 months, and one further follow-up physiotherapy appointment 6 months after the first appointment. This will be a total of 7 physiotherapy sessions of 1.5 hours at the clinical trial sites over 10 months. At the start of the 3rd week of the trial, PBM therapy will commence and proceed as per schedule outlined above.
The eligible participant with Parkinson's Disease will require to have diary observations made by a family member or carer during the study thus both individuals will need to consent to participation in the study.
Intervention code [1] 299624 0
Treatment: Devices
Intervention code [2] 299625 0
Rehabilitation
Comparator / control treatment
No control group. Participants will act as their own control.
In the Brisbane arm of the study, participants will be randomised to receive PBM therapy either with the Vielight device (Brisbane A) or the Irradia device (Brisbane B). All participants in the Sydney arm of the study will receive PBM therapy with the Irradia device.
Control group
Active

Outcomes
Primary outcome [1] 303961 0
Change in Unified Parkinson’s Disease Rating Scale (UPDRS)
Timepoint [1] 303961 0
At baseline and at 40 weeks
Primary outcome [2] 303962 0
Change in Timed Up and Go Test (TUG)
Timepoint [2] 303962 0
Day 1 and at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks and 32 weeks after commencement
Primary outcome [3] 303965 0
Change in Montreal Cognitive Assessment
Timepoint [3] 303965 0
At Day 1 and then at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks and 32 weeks after commencement
Secondary outcome [1] 340545 0
Static and dynamic balance test
Timepoint [1] 340545 0
At Day 1 and then at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks and 32 weeks after commencement
Secondary outcome [2] 340546 0
Composite clinician evaluation of change in cervical spine range of motion, and posterior chain flexibility with tension on both upper limb and lower limb (noted in broad terms as part of routine clinician physical assessment)
Timepoint [2] 340546 0
Baseline assessment & at end of PBMt (anticipated at week 16 into trial)
Secondary outcome [3] 340547 0
Change in 10m walk test
Timepoint [3] 340547 0
Day 1 at entry to trial and then at 2 weeks, 4, 8, 12, 16 and 32 weeks)
Secondary outcome [4] 340548 0
Change in upper limb dexterity and tremor using 9 hole peg test
Timepoint [4] 340548 0
At Day 1 entry to trial and then at 2 weeks, 4, 8, 12, 16 and 32 weeks
Secondary outcome [5] 340550 0
Qualitative observational weekly diary entries to be kept by a family member or carer who lives with primary participant and consents to take part in the study.
Timepoint [5] 340550 0
Day 1 and weekly thereafter for 40 weeks or until end of trial. SMS text message will be sent as weekly reminders.
Secondary outcome [6] 341062 0
Change in upper limb dexterity and tremor using spiral writing test
Timepoint [6] 341062 0
Day 1 on entry to trial and then at 2 weeks, 4, 8, 12, 16 and 32 weeks
Secondary outcome [7] 341063 0
Change in microbiome by studying faecal samples of Sydney trial participants ONLY.
Timepoint [7] 341063 0
3 consecutive days (or bowel evacuations) before treatment begins. The collection will be repeated after 7 days, 28 days of treatment, 56 days of treatment and at the end of treatment (112 days).

Eligibility
Key inclusion criteria
Group 1: Study participants will be those diagnosed by the treating Neurologist as having Parkinson’s Disease that meet the criteria; and
Group 2: A significant family member/carer, nominated by the person in Group 1 and living with the participant with Parkinson’s Disease.

Inclusion criteria Group 1:
• Females and males aged 30–80 years
• Diagnosed with Idiopathic PD (by UK Brain Bank Criteria) with Modified Hoehn & Yahr (H&Y) Stage I-III during ON periods
• More than or equal to 3weeks of stable anti-Parkinson’s Disease medication.

Inclusion criteria Group 2:
• Females and males aged 18 years and over.
• Ability to make observations relating to their spouse/family member or are a significant carer who lives with the participant with Parkinson's Disease as described for Group 1.
• Ability to mark on an observation diary any noted changes in parameters of interest.

Minimum age
30 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: Group 1.
Patients will be excluded from the study, if they:
• Have a cognitive impairment with Montreal Cognitive Assessment (MOCA) score of <24
• History of significant psychotic episode(s) within the previous 12 months
• History of suicidal ideation or attempted suicide within previous 12 months.
• Take potentially photosensitizing medication, especially imipramine, hypericum, phenothiazine, lithium, chloroquine, hydrochlorothiazide, or tetracycline
• Have a history of structural brain disease, active epilepsy, stroke or acute illness, factors affecting gait performance and stance such as severe joint disease, orthopaedic injuries, weakness, peripheral neuropathy with proprioceptive deficits, severe peripheral vascular occlusive disease, severe musculoskeletal disorders, uncorrected vision , vestibular problems or other severe conditions that would:
- preclude the use of PBM therapy
- place the patient at risk during evaluation of their PD, or
- interfere with the evaluation of their PD
• Patients who are currently participating in other trials regarding the treatment of PD, such as advanced therapies (Duodopa, Apomorphine, DBS).

Exclusion criteria Group 2:
• Lack of personal contact on a regular basis with the Group 1 participant with Parkinson's Disease and are unable to comment on sleep characteristics.


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)
Allocation to the study is not concealed. Allocation to a device/intervention group is randomised in the Brisbane arm of the trial where two device options are being tested. Otherwise all other features of the study are standardised between groups.
Participants in the Sydney arm of the trial will be distinguished from the participants in the Brisbane arm of the trial in that the PBMt device is of only one type and the application sites will be different. In the Sydney arm of the trial, faecal samples will be taken in order to investigate the gut-brain axis by evaluating the microbiome. In all other ways, the protocol remains the same.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) will be used to determine which device intervention group a participant will be assigned to in the Brisbane arm of the trial. No randomisation will occur in the Sydney arm of the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
This research most closely aligns with a parallel design in that two different devices will be used at each trial site. In Sydney, the PBMt application targets will be different to the application targets used at the Brisbane trial site. In all other ways, the design features are the same.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Baseline data for all outcome measures collected at initial appointment will form the reference point for analyses. For each outcome measure, descriptive data (mean, standard deviation) will be calculated. From this data, “minimally important difference” (MID) scores will be computed based on ½ SD of each measure. This is a common MID measure (Normal et al, 2003) based on the distribution of the participant scores at baseline and provides a sensitive indicator of significant change over time for N=1 case studies. As such, it does not suffer from a lack of statistical power that would be evident with more traditional ANOVA approaches with small sample sizes. The number of participants showing improvement (i.e., difference between two time points > MID) can be compared between the two PBMt doses (Irradia 904nM vs Vie Light) with chi-square analyses.

The results of this study will inform the researchers as to which dose, if any, influences outcome measures for people with Parkinson’s Disease. The information will provide the foundation dose methodology for a larger placebo controlled trial for this patient population as well as information required to adequately power a larger trial.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW,QLD
Recruitment postcode(s) [1] 18108 0
2076 - Wahroonga
Recruitment postcode(s) [2] 18109 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 297993 0
Charities/Societies/Foundations
Name [1] 297993 0
Cromwell Property Group Foundation
Address [1] 297993 0
200 Mary Street Brisbane Qld 4000
Country [1] 297993 0
Australia
Funding source category [2] 298001 0
Hospital
Name [2] 298001 0
San Hospital Group Sydney
Address [2] 298001 0
185 Fox Valley Road, Wahroonga New South Wales 2076
Country [2] 298001 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Active Rehabilitation Physiotherapy
Address
Level 3 Mater Medical Centre, 293 Vulture Street, South Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 297059 0
Individual
Name [1] 297059 0
A/Prof Liisa Laakso
Address [1] 297059 0
School of Allied Health Sciences, Griffith University
Gold Coast Qld 4222
Country [1] 297059 0
Australia
Secondary sponsor category [2] 297066 0
Individual
Name [2] 297066 0
Mr John Fitzgerald (Active Rehabilitation CEO)
Address [2] 297066 0
Level 3, 293 Vulture Street, South Brisbane Qld 4101
Country [2] 297066 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299032 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 299032 0
Research Ethics and Integrity
Office for Research
Nathan campus, Griffith University, 170 Kessels Road QLD 4111
Ethics committee country [1] 299032 0
Australia
Date submitted for ethics approval [1] 299032 0
17/11/2017
Approval date [1] 299032 0
Ethics approval number [1] 299032 0

Summary
Brief summary
Purpose of the Study
This study seeks to evaluate the effect of a slowly increasing dose of PBMt (number of sessions per week) on the signs and symptoms of Parkinson’s disease whilst participants are also receiving usual care physiotherapy. The doses will be slowly increased each four weeks and there will be three dose variations evaluated. We will measure the effects of the treatments in two ways throughout this period:
a) at home by observations made by the chosen significant other/carer
b) in the clinical setting with specialist and physiotherapy evaluations.
Also, there will be two different forms of medical light trialled:
a) one that could eventually be recommended for home use, and
b) one that is a clinic based therapy.
In this study, the medical light will be applied by a trained physiotherapist to the head (in Brisbane arm of trial) or other parts of the body (spine and abdomen in Sydney arm of trial). In the Brisbane arm, participants will be randomly allocated into receiving one of two forms of light device. In the Sydney arm of the trial, only one device will be trialled and evaluation of the gut microbiome will be added to the outcome measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79054 0
Dr Joanne Bullock-Saxton (Research Manager)
Address 79054 0
Active Rehabilitation Physiotherapy
Level 3 Mater Medical Centre, 293 Vulture Street, South Brisbane QLD 4101
Country 79054 0
Australia
Phone 79054 0
+61 7 3163 1188
Fax 79054 0
+61 7 3163 1192
Email 79054 0
Joanne.Bullock-Saxton@activerehab.com.au
Contact person for public queries
Name 79055 0
Dr Joanne Bullock-Saxton (Research Manager)
Address 79055 0
Active Rehabilitation Physiotherapy
Level 3 Mater Medical Centre, 293 Vulture Street, South Brisbane QLD 4101
Country 79055 0
Australia
Phone 79055 0
+61 7 3163 1188
Fax 79055 0
+61 7 3163 1192
Email 79055 0
Joanne.Bullock-Saxton@activerehab.com.au
Contact person for scientific queries
Name 79056 0
A/Prof Liisa Laakso
Address 79056 0
School of Allied Health Sciences
Griffith University
Gold Coast campus Qld 4222
Country 79056 0
Australia
Phone 79056 0
+61 7 5552 9122
Fax 79056 0
+61 7 5552 8674
Email 79056 0
L.Laakso@griffith.edu.au

No data has been provided for results reporting
Summary results
Not applicable