Innovative device set to improve treatment for Parkinson’s disease
Pictured, from left, Chief Scientific Officer DBS Tech, Professor Hugh McDermott; Senior Engineer DBS Tech, George Bartholomew; Chief Operating Officer DBS Tech, Dr Paul Minty; and Senior Research Engineer DBS Tech, Dr Matt Petoe with elements of the ASTUTE prototype ready for clinical testing.
More than 10 million people worldwide are currently living with Parkinson's disease. In Australia, this degenerative neurological disorder affects 100,000 people, and 38 new cases emerge each day.1 Around 20 per cent of patients are diagnosed before the age of 50, which understandably has a life-altering effect on the individual, but also contributes to lost economic productivity.2
Parkinson's disease is characterised by progressive and debilitating loss of control of movement, with symptoms including tremors, slowness, and muscle rigidity. Although helpful, medications do not adequately control motor symptoms in approximately 20 per cent of patients. These patients can be helped by Deep Brain Stimulation (DBS): an established electroceutical therapy where electrical impulses are delivered via electrodes implanted into the brain. Although DBS improves quality of life, conventional devices have limitations that diminish patient outcomes.
The main limitation of present-day DBS systems is the fixed setting for stimulation, regardless of each patient’s continually changing needs. Under-stimulation can increase motor symptoms, while over-stimulation can increase side effects, including cognitive-motor (e.g., speech) and psychiatric (e.g., depression) disturbances.
Almost all users of conventional DBS systems require the settings to be adjusted frequently. These adjustments are performed manually by experienced clinicians approximately every two months; however, it is not feasible for clinicians to explore all available setting combinations during each adjustment, so the optimum benefit is often not achieved. Yet sometimes even a small change can suddenly liberate a patient from months or years of poor function.
One organisation that’s making headway in this space is Deep Brain Stimulation Technologies Pty Ltd (DBS Tech) – a start-up company that was spun out of the Bionics Institute in late 2019. Professor Hugh McDermott, Chief Scientific Officer, and Dr Paul Minty, Chief Operations Officer, lead and manage the company's variety of research and development streams.
Seeded by private investment, the company was founded with the goal of improving the lives of people living with neurological disorders through agile research and development of innovative forms of electrical therapies, including the DBS therapy used for Parkinson’s disease. DBS Tech is developing extensions to a breakthrough discovery made by the Bionics Institute of a novel brain signal. Known as Evoked Resonant Neural Activity (ERNA), this robust and reliable brain signal is evoked in the brain by DBS. The team’s previous work showed that its properties change systematically as DBS efficacy increases – making it an ideal electric biomarker.
DBS Tech is now working to develop an innovative deep brain stimulation device called ASTUTE: Adaptive Stimulation Technique Upgrading Therapeutic Efficacy. This device will use the ERNA brain signal to adjust stimulation automatically – this adaptive feature, overcomes the limitations of conventional systems, reducing the need for adjustment visits and improving quality of life for people living with Parkinson’s disease.
Pictured: Prototype ASTUTE deep brain stimulation system. Shown are the Printed Circuit Board Assembly (PCBA; front) that is placed within the Implantable Pulse Generator (IPG; centre) at the heart of the system; the IPG is compatible with commercial DBS electrode leads. Also shown, the battery charger (back left) and remote control used to program the IPG (back right). Credit: Paul Minty
DBS Tech was awarded $1 million in matched funding during Round 1 of MTPConnect’s Biomedical Translation Bridge (BTB) program (an MRFF initiative). Through the program, the company was supported by venture partner, the Medical Device Partnering Program (MDPP), to help it produce the first prototype ASTUTE system for initial clinical trials. Project goals included the development of the implantable pulse generator (IPG) at the heart of the system – which can sense and respond to neural signals – as well as a battery charging device and an external programming device. DBS Tech successfully met all these milestones, with the design of the implant, battery charging unit and programming unit all translated to the manufacturer. These components are now ready for manufacture and implant into the first patients.
Thanks to the BTB funding award, DBS Tech gained new IP and knowledge from overseas; the team also enhanced its capability for future collaborations and clinical trials involving other brain disorders. The research version of the prototype ASTUTE device, which consists of a ‘smart’ human-grade bionic implant, will be attractive to other researchers and companies that are developing new active implantable medical devices. An additional top-up funding of $100,000 facilitated the preparation of safety documentation required for future clinical trials and regulatory submissions, and review of these documents by a specialist auditor to give assurance that the safety validation work is up to current standards.
The prototype ASTUTE deep brain stimulation device will be used with a patient for the first time during 2023, as part of the product development plan. Subsequently, the final version of the device will be trialled, which will hopefully show benefits for Australians living with Parkinson's disease as well as the local clinical trial sector. Ultimately, the main beneficiaries will be people living with the condition, who will be able to access a commercial product with DBS Tech’s technology within the next five years.
DBS Tech has established a pathway to global commercialisation with a leading manufacturer and distributor of DBS systems. After commercialisation, the research and development team will be integrated into global supply chains for the ongoing enhancement of brain signal analysis and adaptive control algorithms for the commercial products. These products will be marketed by DBS Tech’s global partner – paving the way for better treatment outcomes for people with Parkinson’s disease all around the world.
Sources
1. https://shakeitup.org.au/understanding-parkinsons/