Key Facts:
- This landmark trial is the largest-to-date and was only made possible because of the seminal work of Australian scientists from the University of Sydney.
- Participants who continued treatment in Stage 3 improved in functional mobility by +14% compared with a 5% decline in those who discontinued.
- Parkinson's severity scores saw a 20% improvement for those who continued with active therapy vs +11% without.
- Anxiety scores also improved significantly in the participants who continued treatment in stage 3 by 11% compared with a 6% worsening in those who discontinued, highlighting broader quality of life impacts.
- SYMBYX Biome, a Sydney-based MedTech start-up backed by Australian Investors, has developed this non-invasive, at-home therapy that is already providing meaningful relief to people living with Parkinson's across Australia.
New study shows that participants using light therapy devices over several months experienced significant improvements in balance, gait, and anxiety.
Australian-founded medical technology company SYMBYX today announced compelling results from a 72-week randomised controlled trial (RCT) demonstrating improvements in a range of Parkinson's disease symptoms. These results provide further evidence that light therapy, especially when combined with exercise, can be a safe adjunct therapy for people living with Parkinson's.
"His quality of life has substantially improved, there is just no doubt about that'" said Ruth, carer for Peter, a participant in the clinical trial.
"I found with the light treatment, I had much more energy," added participant Andy, who used the SYMBYX devices as part of the clinical trial.
Conducted at the Parkinson's Wellness Innovation Centre in Ontario, Canada, and led by co-principal researchers Anita Saltmarche (BScN, MHSc) and Orla Hares (BSc, Hon PT), this study involved 59 participants with moderate Parkinson's disease. The trial compared two groups: one receiving active light therapy treatment directed towards the gut combined with a transcranial helmet, while the other group received a sham treatment. Both groups participated in a prescribed exercise program.
Participants completed two initial stages: Stage 1 involved eight weeks of either active or sham therapy, and Stage 2 involved an additional eight weeks of active treatment for everyone. After these first two stages, both groups improved in a range of areas, confirming a widely anticipated short-term placebo effect. However, after Stage 3 - involving 43 participants (73% of the starting cohort) under open-label conditions for an average of 28.7 weeks - a group of 17 participants who continued with light therapy during Stage 3 showed significant further improvements versus the remaining 26 who did not.
The following outcomes were recorded at baseline and after each stage. Please note that each participant had received at least 1 or 2 stages (8-16 weeks) of light therapy before Stage 3 commenced.
- Functional Mobility: Timed Up and Go ("TUG") scores improved by 14% over baseline among participants who continued treatment in Stage 3, compared with a 5% worsening in those who discontinued.
- Unified Parkinson's Disease Rating Scale (MDS-UPDRS total score): The MDS-UPDRS is the gold-standard measure of Parkinson's progression – typically, patients experience an average deterioration of 4.7 points (equating to an increase in the raw score) per year. Participants who continued treatment in Stage 3 improved by 20% over baseline (12-point decrease), compared with an 11% improvement (7-point decrease) in those who discontinued.
- Activities of Daily Living (MDS-UPDRS Part II): Participants who continued treatment in Stage 3 improved by 32% over baseline (5-point decrease), compared with a 20% improvement (3-point decrease) in those who discontinued.
- Motor Examination (MDS-UPDRS Part III): Participants who continued treatment in Stage 3 improved by 19% (5-point decrease), compared with a 13% improvement (3-point decrease) in those who discontinued.
- Anxiety (Beck Anxiety Score): Participants who continued treatment in Stage 3 improved by 11%, compared with a 6% worsening in those who discontinued.
Anita Saltmarche, Co-Principal Investigator, commented:
"These results provide further support for the use of light as a safe, effective, research-based treatment for Parkinson's symptoms. Based on standardized testing, participants demonstrated significant improvements in both their motor and non-motor symptoms, resulting in meaningful improvements in their quality of life and that of their families."
Orla Hares, Co-Principal Investigator, added:
"Being part of a trial demonstrating significant improvements using reliable, gold-standard outcome measures is incredibly meaningful. It allows us to confidently implement therapies in the clinic that we know make a real difference in our clients."
Dr Wayne Markman, CEO of SYMBYX said:
"We've learned a lot from this research – that future light therapy trials need to be of longer duration because a slower and more consistent approach definitely pays off. I'm really looking forward to the next large clinical study with Newcastle University, UK, along with a bio-marker component by The University of Leeds."
