Track Record: Monitoring and predicting seizures in epilepsy
In collaboration with epilepsy specialist Professor Mark Cook, researchers at the Bionics Institute developed the first-generation Minder device, which went into clinical trials in 2019 to monitor seizures in epilepsy.
Clinical challenge
Professor Mark Cook, Director of Neurology at St Vincent’s Hospital identified the need for a medical device to record seizures in epilepsy patients over months and years. This is because neurologists currently rely on self-reported occurrences and EEG recordings taken during clinic visits to titrate seizure control medication.
Ideation, design and prototyping
Associate Professor Chris Williams and engineers at the Bionics Institute worked closely with Professor Cook to develop a minimally invasive sub-scalp implant to monitor seizures over time, leveraging their extensive expertise with implantable device technology.
Proof of principle efficacy trials
Between 2014 and 2017, the Bionics Institute team developed different types of electrodes and surgical approaches, carrying out preclinical validation in ‘proof of principle’ animal model safety and efficacy trials.
Regulatory pathways and intellectual property
Since 2016, the team has filed a number of patents to protect the novel electrode design which facilitates recording of brain activity. Coupled with implantable recording electronics, the captured brain activity is sent continuously to a phone then to the cloud for analysis. Spin off company, Epi-Minder Pty Ltd was established in June 2018 to commercialise the device. Regulatory filings in the US and Europe will be supported by clinical trial data.
First-in-human clinical trials
The first-in-human devices were manufactured in Australia with clinical trials in humans commencing in 2019. To date, a number of people have successfully received the Minder™ system at St Vincent’s Hospital, Melbourne.
Patient impact
Professor Cook says: “Patients are often unaware of their seizures, but the device gives me a read out of all the seizures actually happening, allowing me to calibrate medication more accurately. Ultimately this will give trial participants better control over their seizures.”
Clinical trials and the next step: predicting seizures
Preparations are underway for a pivotal clinical trial with a larger number of patients. Epi-Minder has joined forces with Seer Medical to develop software that, not only records, but also predicts seizures, allowing patients to receive notification via a smartphone app and potentially move to safety.