The world's biggest clinical trial using Electroencephalography (EEG) Neurofeedback as a therapy to manage chronic pain has been launched in New Zealand.
The clinical trial, funded by New Zealand-based health tech company Exsurgo, is being led by researchers at AUT and Waitematā District Health Board.
EEG Neurofeedback is a non-invasive therapy that works by monitoring brain activity and using that data to help the patient 'retrain' how their brain responds to nerve signals from the body.
More than 100 people who suffer from chronic pain will wear a custom Axon EEG headset developed by Exsurgo. The headset reads the bio-electrical activity associated with pain and sends real-time data to a mobile device. Participants will undertake a series of simple exercises, in the form of animated games on a smartphone or tablet, while wearing the headset. These exercises are designed to reward and reinforce positive change in the brain's electrical activity.
Through regular use of the at-home Axon system, for 30 minutes a day over several weeks, the patient effectively learns to retrain how their brain perceives and responds to pain. This process is called neuromodulation.
Chronic pain, which is defined as pain that persists for more than three months, affects up to one in five people worldwide. The estimated annual cost of chronic pain in New Zealand is as much as $14 billion – more than diabetes, dementia, and smoking.
The primary investigator, Dr David Rice – Senior Lecturer in Physiotherapy and Associate Head of Research at the AUT School of Clinical Sciences – says, chronic pain is common, complex, and hard to treat.
"It is estimated that one in five New Zealanders suffer from chronic pain, which can severely impact both their physical and psychological wellbeing. Increasingly, we are finding evidence that chronic pain is driven by changes to pain pathways in the brain and so this trial is seeking to find whether the Axon headset can target these changes to effectively treat chronic pain," he says.
Rice is the current President of the New Zealand Pain Society and also has an appointment at Waitematā DHB's Pain Service in the Department of Anaesthesia at North Shore Hospital.
The New Zealand trial follows an initial proof-of-concept clinical trial in the UK in 2020, where three-quarters of the participants reported a reduction in pain of at least 30 percent. Participants also reported a significant reduction in anxiety and depression, as well as improvements in sleep patterns and overall quality of life.
Exsurgo Chief Science Officer, Christine Ozolins – a lead investigator on the clinical trial – says, EEG Neurofeedback has potential advantages over traditional drug-based therapies which can carry the risk of side effects and addiction.
"Chronic pain, and the associated problems that drug-based therapies bring to this condition, is one of the biggest healthcare issues facing the world today. The very promising results from the proof-of-concept UK trial has given us the confidence to move forward with this much larger trial in New Zealand. It is our hope that the trial will demonstrate the Axon headset as another tool in the toolbox for treating chronic pain," says Ozolins.
Conventional EEG Neurofeedback is complicated and costly, requiring the patient to attend a specialist clinic, a clinician to be present to interpret brain activity data, and systems that can cost hundreds of thousands of dollars.
Exsurgo is leveraging miniaturised technology, advanced data analytics, and artificial intelligence to transform EEG Neurofeedback into a cost-effective, mobile system for use in a clinical setting or in the home.
AUT Deputy Vice Chancellor Research, Professor Kath McPherson, says AUT is delighted to partner with industry.
"It's really great when inventors like [Exsurgo CEO] Richard Little welcome the knowledge, expertise, and independence our researchers can bring. At times we work with industry in developing technology and products, but this project demonstrates the key role we can play in bringing informed independent to evaluation," says McPherson.
Axon headset in use