A new approach to epilepsy diagnosis
Over 250,000 Australians are currently living with epilepsy, which is one of the most common brain disorders worldwide and can affect people at any stage of their lives. Diagnosis can be difficult in some people, while others experience problems with effectively managing their seizures through drug therapies.
A definite diagnosis of epilepsy can be challenging in some patients, especially if seizure-like events are infrequent. Currently, conventional EEG recordings are used to detect epileptic events, but this clinical tool has its limitations. It is not possible for the EEG electrodes to be fixed to the scalp for prolonged periods, and repeated in-patient monitoring sessions are very expensive and may not capture an event.
Conventional EEG recordings are also unsatisfactory for another major problem faced by clinicians – the sometimes difficult management of drug therapies to relieve seizures and the reliance on patient diaries. In some patients, getting the drug regime correct can be a lengthy, trial and error process.
To address these clinical issues we need a means of continuously recording brain activity over long periods. This would have a profound impact on the lives of individuals and their carers, as well as the clinicians who manage their treatment.
Patients with undiagnosed epilepsy and those experiencing difficulty in epilepsy drug management face ongoing stress, risks, and uncertainty when carrying out their normal daily activities.
For over a decade, the Bionics Institute, with its collaborators at St Vincent’s Hospital Melbourne and the University of Melbourne, have been researching and developing the concept of a small implantable device to improve the diagnosis and management of epilepsy and seizure-related conditions. Our approach has been to develop a small, thin and flexible implant to be inserted under the scalp that will allow the long-term monitoring of brain activity. This will require minimal surgery and risk, in much the same way as implantable monitors are currently used to diagnose heart abnormalities.
We have called this device MINDER and it is designed to reliably monitor seizures outside of the clinic as patients go about their daily lives. We recently completed the critical pre-clinical studies to test that the sub-scalp system is safe and effective. We continue to refine the prototype implant and its associated recording hardware and software, determine its best placement and stability, as well as develop specialised surgical instruments for its implantation.
The research team envisages that a future device will also have the capability of improving patient safety through remote monitoring and incorporating a ‘call-home’ function to alert carers of a seizure.
Our research to date has provided the crucial groundwork for a future clinical trial expected to commence in late 2019.
In June 2018 this research culminated in the establishment of the new start-up company Epi-Minder Pty Ltd, which will enable clinical trial and commercialisation of our seizure monitoring device. This new Australian venture has received initial investment from Cochlear Limited and Australian private investors (see press release).