Trial conducted at Sydney’s San Hospital, team led by the Director of Research, Dr Geoff Herkes
Material improvement in final 12 weeks by patients who were part of the initial placebo group
Parkinson’s disease is the fastest-growing neurological disorder in the world, second only to dementia
SYMBYX Biome, an Australian med-tech business, today announced encouraging results from a Sydney Adventist Hospital (commonly known as the San) trial. These results are the six month follow- up results from a triple-blinded, randomised controlled trial run by the San which investigated the efficacy of the SYMBYX Neuro, a new red/infrared light therapy helmet device on People with Parkinson’s (PWP).
The latest results follow an initial 12 week trial recently published in the Journal of Clinical Medicine. The trial was conducted remotely (ie, at home) under the supervision of a large clinical team headed by San Director of Research and Neurologist, Dr Geoffrey Herkes (MBBS, PhD, FRACP).
San trial participants were initially split into two groups of 20 each, with one group receiving infrared & red light treatment (the “Active” group) from the SYMBYX Neuro helmet, while the other received a fake treatment (the “Sham” group). The standardised Parkinson’s Disease rating Scale (MDS-UPDRS- III) was used to rate patient improvements. The testing was conducted at Baseline, after 12 weeks and, again, after 24 weeks or six months.
The original 12-week Sham group moved on to Active treatment and showed a material improvement over both their Baseline condition as well as their condition after the first 12 weeks of Sham treatment.
“It is not uncommon for a Sham group to experience improvements, even though their treatment was in fact Sham or fake”, said Dr Herkes. “Parkinson’s patients are typically very motivated in a new trial situation and the very idea of any new form of treatment is often sufficient to naturally increase dopamine production, even for a short period of time,” he said.
“It is also apparent and very pleasing to note that the second phase results clearly demonstrate the positive benefits of a course of transcranial light therapy,” Dr Herkes added.
After the Cross-Over phase of the San trial commenced (ie, the point at which the original Sham patients were informed of their Sham treatment and allowed to commence a 12 week period of Active treatment), approximately 65% took the offer up to complete the standard 12 week trial protocol. The original Active participants stopped live at the initial 12 week mark and entered what is called the
“Washout” period. This period is when all trial treatment is ceased and the patient is essentially withdrawn completely from the trial.
Both groups were assessed at Baseline, 12 weeks and 24 weeks and the following results were recorded:
- The original Sham group improved by 15% after an initial 12 weeks of the fake treatment; this is what is known as a “Placebo” effect.
- This same group then improved by an additional 20% following 12 weeks of the Active treatment; this result shows that there is a real benefit above the “Placebo” effect.
- The original Active group which stopped treatment after an initial 12 weeks (to enter what is known as a “Washout” period) lost none of the initial gains recorded during the Active treatment, even after 12 weeks of no treatment.
- During the original Active period, Neuro participants recorded a 21% improvement after 12 weeks on the SYMBYX protocol.
SYMBYX Chief Executive Dr Wayne Markman said: “The original Active group (which initially received 12 weeks of live treatment) showed practically no dilution of the positive benefits achieved after a 12 weeks ‘Washout’ period. This is very exciting news and starts to suggest that the therapy is indeed showing a capacity to slow or even modify disease progression.” Dr Markman said the findings from the second phase are also in the process of being peer-reviewed with publication scheduled in a recognised medical journal in coming months.
Parkinson’s disease is the fastest-growing neurological disorder in the world and is now only second to dementia. The prevalence of Parkinson’s is also increasing in younger people - 1 in 5 newly diagnosed are under 50 years old and 10% are under 40 years. Australians unfortunately follow these global trends closely. It is a progressive neurological condition caused by a lack of dopamine, a chemical used by the brain to help initiate and control body movement. Symptoms include muscle rigidity, tremor, difficulty walking as well as depression, anxiety, compromised swallowing and loss of sense of smell. In addition to the 12 million people diagnosed worldwide (which excludes numbers from India and China), it is estimated that three to four times more people have undiagnosed early signs and symptoms. Parkinson’s is now the world’s fastest-growing neurodegenerative disorder.
Light therapy (often referred to as Photobiomodulation), works in several ways to reduce Parkinson’s symptoms:
Targeting cell mitochondria, where chemical energy known as ATP, driving all human life, is produced. Low energy or fatigue is a common symptom of Parkinson’s.
Targeting the gut where neuro-transmitters, in short supply in Parkinson’s, are manufactured. Over 50 percent of our dopamine and 85 percent of our serotonin is produced in the gut. Light therapy treatment, therefore, has a typically positive cognitive effect, reducing ‘brain fog’ while improving sleep, speech, mood and initiative. Motor improvements include balance, gait and fine motor control such as handwriting.
Modulating ion channels in nerves resulting in reduced pain associated with muscle spasm, rigidity and postural problems;
Reducing systemic inflammation through the production of anti-inflammatory biomarkers.
People living with Parkinson’s who have used light therapy on their gut and/or transcranial, have returned to activities they previously enjoyed such as playing the piano, shopping, carrying groceries and also gardening more easily. Some have also had improvements in their sense of smell, digestion, sleep and energy levels.
Earlier trials conducted in Adelaide (published in BMC Neurology UK, 2021) and Sydney (published in Photobiomodulation, Photomedicine and Laser Surgery, 2022), showed significant reductions in patient symptoms. Patients previously treated with PBM have returned to playing the piano, and report being able to shop, carry groceries and garden more easily. Some have recovered their sense of smell. The cross-over phase of the SAN trial is currently under review at a major peer-reviewed medical journal, and has been presented at the most recent Amercian Academy of Neurology annual meeting in Boston (April 2023).
Dr Markman, SYMBYX Biome CEO, and Dr Herkes are available for interview.
For media inquiries, contact Ian Pemberton at P&L Corporate Communications in Sydney on +61 402 256 576