None listed
Conditions
Brief summary
Purpose of the Study This study seeks to evaluate the effect of a slowly increasing or decreasing doses of PBMt (number of sessions per week) on the signs and symptoms of Parkinson’s disease whilst participants may also be receiving usual care physiotherapy. The doses will be slowly altered each four weeks and there will be four 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), and in combination (head, spine and abdomen) in the Adelaide arm. In the Brisbane, 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. In the Adelaide arm, the two devices will be used and the gut microbiome will be analysed as well.
Interventions
Intervention: Photobiomodulation therapy (PBMt) All participants in Sydney and Brisbane arms will receive usual care physiotherapy regardless of the PBMt intervention; and participants in Adelaide arm will receive only PBMt. 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 four 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 participants 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 in the Brisbane and Adelaide arms 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 the Brisbane, Sydney and Adelaide 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. In the third arm of the trial in Adelaide, both the Vielight (to the skull) and the Irradia (to remote sites at the abdomen) devices will be used to test the findings from animal research that remote application has an effect on outcomes. 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 and according to the trial site protocol. In Brisbane, 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. In the Adelaide arm, participants will enter the PBMt intervention stage from the outset and will have no other physiotherapy intervention. A dose de-escalation protocol will be utilised in Adelaide. 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.
Sponsors
Study design
Eligibility
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.
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.