Does light therapy affect quality of life and movement in people with Parkinson's Disease?

INTERVENTION: 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. The order of visitations is as follows: CONDITION: Parkinson's Disease PRIMARY OUTCOME: Change in Montreal Cognitive Assessment Change in Timed Up and Go Test (TUG) Change in Unified Parkinson’s Disease Rating Scale (UPDRS) ; Static and dynamic balance test 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. 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. 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 ses SECONDARY OUTCOME: Change in 10m walk test Change in microbiome by studying faecal samples of Sydney trial participants ONLY. Change in upper limb dexterity and tremor using 9 hole peg test Change in upper limb dexterity and tremor using spiral writing test 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) 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. 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.