None listed
Conditions
Brief summary
The main aim of this study is to investigate the safety and feasibility of transcranial photobiomodulation intervention, using infrared LEDs, for patients diagnosed with Parkinson's disease. It is hypothesised that the application of transcranial photobiomodulation might produce clinically meaningful improvements in the quality of life for people living with Parkinson's disease. This feasibility study will inform on a larger, adequately powered randomised placebo-controlled clinical trial.
Interventions
Participants in the treatment group will receive photobiomodulation (infra-red light) intervention via an external transcranial device that is worn on the head. Participants will receive photobiomodulation intervention to 20 separate locations on the head 6 times per week for a total of 12 treatment weeks. Each treatment session will last for 24 minutes with a total energy absorption of 154.5 joules. Participants in the placebo group will receive the same intervention protocol as the treatment g
Participants in the treatment group will receive photobiomodulation (infra-red light) intervention via an external transcranial device that is worn on the head. Participants will receive photobiomodulation intervention to 20 separate locations on the head 6 times per week for a total of 12 treatment weeks. Each treatment session will last for 24 minutes with a total energy absorption of 154.5 joules. Participants in the placebo group will receive the same intervention protocol as the treatment group delivered using a structurally identical sham transcranial device that delivers no infra-red light. Participants will be contacted by Zoom at weekly intervals for the first 4 weeks and at fortnightly intervals thereafter to monitor their adherence to the intervention and the safety of the intervention. At the conclusion of the 12 weeks of active treatment, participants will receive no treatment for 12 weeks. At the conclusion of 12 weeks of sham treatment, participants will be offered 12 weeks of active treatment
Sponsors
SYMBYX Biome
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Females and males diagnosed with Idiopathic Parkinson's disease (by UK Brain Bank Criteria) with Modified Hoen & Yahr staging of I - III during ON periods, and with 3 or more weeks of stable anti-Parkinson's disease medication. Sufficient space at home (around 9 m2) to be able to perform motor assessments; Stable and sufficiently fast home-based internet connection for uninterrupted video calls and video conferencing; Knowledge (self or carer) of using a phone and/or tablet applications on either IOS or Android platforms
Exclusion criteria
Participants with the following will be excluded from the study, if they: are incapable of self-care; have cognitive impairment with a MoCa score of <24; history of significant psychotic episode(s) within the last 12-months; history of suicidal ideation or attempted suicide within the last 12-months; take potentially photosensitising 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 (such as those that preclude the use of photobiomodulation therapy, that places the patient at risk during evaluation of their Parkinson's disease, or interferes with the evaluation of their Parkinson's disease); have cardiac disease; are currently participating other trials regarding the treatment of Parkinson's disease, such as advanced therapies (including Duodopa, Apomorphine, Deep Brain Stimulation).
Outcome results
None listed