World’s Largest Clinical Trial Of Electroencephalography (EEG) Neurofeedback For Pain Launches In New Zealand

The world’s biggest clinical trial using EEG neurofeedback as a therapy to manage chronic pain has been launched in New Zealand.

Chronic pain (defined as pain that persists for longer than three months) affects up to one in five people around the world and is a massive burden on healthcare systems and economies. A 2018 report commissioned by the Australian and New Zealand College of Anaesthetists (ANZCA) estimated the total annual cost to New Zealand of chronic pain at $13-14.9 billion - greater than those for diabetes, dementia and smoking.[1]

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.

The trial is funded by New Zealand-based health tech company Exsurgo and is being led by researchers from Auckland University of Technology (AUT) and Waitematā District Health Board (Waitematā DHB) and is happening despite New Zealand’s Covid Alert levels.

In the trial, 116 participants who suffer from chronic pain will wear a custom designed Axon EEG headset developed by Exsurgo. The headset passively reads the bio-electrical activity associated with pain in the participant’s brain and sends this data wirelessly to a mobile device in real-time. As they wear the headset, participants undertake exercises (in the form of simple animated games played on a tablet or smartphone). These exercises reward and reinforce positive change in the brain’s electrical activity.

By using the Axon system on a regular basis (about 30 minutes per day over the course of several weeks), the patient learns to ‘retrain’ how their brain perceives and responds to pain. This process is called “neuromodulation”.

Dr David Rice, Associate Head of Research & Senior Lecturer School of Clinical Sciences at AUT and primary investigator, says that chronic pain is common, complex and hard to treat.

“It is estimated that one in five New Zealanders suffer from chronic pain[2] which can severely impact 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.”

The New Zealand trial follows an initial Proof of Concept clinical trial in the United Kingdom, conducted during 2020. In the UK study, three-quarters of patients reported a reduction in pain of at least 30% (considered to be a clinically significant improvement). Patients also reported significant reductions in anxiety and depression, as well as improvements in sleep patterns and overall quality of life.

Exsurgo Chief Science Officer, Christine Ozolins is a lead investigator on the clinical trial and says EEG Neurofeedback has potential advantages over traditional drug-based therapies which can carry risks of side effects and addiction concerns.

“Chronic pain and the associated problems that drug-based therapies bring to this condition, are one of the biggest healthcare issues facing the world today. The very promising results from our 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.”

Conventional EEG Neurofeedback is complicated and costly for both patient and doctor requiring attendance at a specialist clinic and for a clinician to be present to interpret the brain activity data, using systems that cost in the tens to hundreds of thousands of dollars.

While existing EEG science underpins Axon, Exsurgo is leveraging miniaturised technology, advanced data analytics and artificial intelligence to transform EEG Neurofeedback into a cost-effective, mobile system that can be used in a professional clinical setting or at a patient’s home.

People who have had moderate to severe pain for at least three months and meet other specified trial criteria will be eligible to participate in the trial. Participants in the New Zealand trial will receive a training session in person or online and will complete the remainder of the treatment in the comfort of their own home for the duration of the trial.

About EEG Neurofeedback

EEG (short for Electroencephalography) Neurofeedback leverages the neuroscience of how your brain works to respond to and control your body, as it receives and sends bio-electrical signals via your nervous system.

It is an established form of therapy with proven clinical trials published since the 1950s and growing evidence of its effectiveness across a range of ailments – chronic pain, anxiety, depression and many others.

About Exsurgo

Exsurgo is a neuroscience company developing technologies to provide a wide range of neurological treatments, services and devices, underpinned by an AI-enabled, Cloud-based data analytics platform.

Exsurgo’s immediate focus is on a range of services involving EEG (short for Electroencephalography) Neurofeedback, a long-established, non-invasive, drug-free therapy for a wide range of neurological conditions including chronic pain.

The Axon headset is a custom-designed EEG headset (a Brain Computer Interface or BCI) that passively reads the bio-electrical activity associated with pain in the patient’s brain.

About AUT

Auckland University of Technology (AUT) is one of New Zealand’s leading universities, ranked in the top 1% of universities worldwide and the highest ranked university in Australia for global research impact.[3]

About Waitematā District Health Board (Waitematā DHB)

Waitematā is the largest and one of the most rapidly growing DHBs in New Zealand, serving a population of around 650,000 across Auckland’s North Shore, Waitakere and Rodney areas. Waitematā DHB employs more than 8,500 people across more than 80 locations and in addition to providing care to their own resident population, is New Zealand’s Northern Region provider of forensic mental health services and child rehabilitation services, plus the metro Auckland provider of child community dental services and community alcohol and drug services. Although Waitematā DHB’s services are carried out mostly within the Auckland metropolitan area, the chronic pain trial is open to patients from across New Zealand.

Biographies

Richard Little – Exsurgo CEO

Richard Little is driven by improving the lives of people through harnessing the latest in science and technology. An engineer by training, an inventor through passion, and an entrepreneur in spirit, Little has been involved over the past three decades as a founder, director or investor in a range of medical technology ventures. Richard’s previous enterprise Rex Bionics was listed in an IPO in 2014 on the UK AIM stock exchange.

Christine Ozolins – Exsurgo Chief Science Officer

Christine Ozolins is a Psychologist and Cognitive Neuroscientist, specialising in neuroimaging and brain modulation techniques. Christine has worked in academic research with healthy, sub-clinical and clinical populations, including clinical trials involving paediatric, geriatric and chronic pain patients. Christine first encountered neurofeedback in 2015 in London. She was inspired by how neurofeedback could combine behavioural psychology with neuroscientific principles, to help people self-regulate their brain activity, with a wide range of applications.

Dr David Rice – AUT University

Dr David Rice is Associate Head of Research in the School of Clinical Sciences and a Senior Lecturer in the Department of Physiotherapy at AUT. David also has an appointment at Waitematā DHB’s Pain Service in the Department of Anaesthesia at North Shore Hospital and is the current President of the New Zealand Pain Society. His research interests are in the neuromuscular consequences of joint injury and arthritis, enhanced recovery after surgery and the mechanisms and management of chronic pain conditions.

[1] https://www.srgexpert.com/wp-content/uploads/2019/03/The-problem-of-chronic-pain-and-scope-for-improvements-in-patient-outcomes.pdf

2 Health and Independence Report 2017 The Director-General of Health’s Annual Report on the State of Public Health

3 Times Higher Education World University Rankings 2022.

Please click here to download images of Exsurgo team and the Axon headset.

[1] https://www.srgexpert.com/wp-content/uploads/2019/03/The-problem-of-chronic-pain-and-scope-for-improvements-in-patient-outcomes.pdf

[2] https://www.srgexpert.com/wp-content/uploads/2019/03/The-problem-of-chronic-pain-and-scope-for-improvements-in-patient-outcomes.pdf

[3] Times Higher Education World University Rankings 2022.

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