Interactive Nerve Pain Game Enters Clinical Trials

Researchers have spent three years developing an accessible, at-home intervention for people with nerve pain from spinal cord injury.

Scientists from UNSW Sydney have developed an interactive software which could be used to help people who are experiencing neuropathic pain – also known as nerve pain – as a result of spinal cord injury (SCI).

The intervention, called PainWaive, involves a headset and a game that measures electrical activity in the brain. The system aims to enable users to manage their pain by learning to regulate the abnormal brain activity associated with neuropathic pain.

Professor Sylvia Gustin and Dr Negin Hesam-Shariati, who are leading the multidisciplinary team based at UNSW Science and Neuroscience Research Australia (NeuRA), recently published a study in the Nature journal Spinal Cord, with a comprehensive description of the intervention.

"The novelty of this treatment is that it is home based, so people don't need to go to the clinics. They would be able to use the system in their safe environment at home," says Prof. Gustin. "This is really important if you have people with limited mobility, but also people who live in regional and rural areas, who have limited access to healthcare facilities."

After many years of development, which involved input from people affected by SCI, the team have recently completed a pilot study, and will begin to recruit for a randomised controlled trial, for PainWaive, commencing in 2025.

Nerve pain caused by spinal cord injury

Although loss of mobility is often considered the most serious consequence of SCI, people with SCI consistently rate neuropathic pain, as one of the most difficult and debilitating problems they have to deal with.

"We know that approximately 50–70% of people who have a spinal cord injury develop nerve pain in areas where they can't feel or move, or can only partially feel or partially move," says Prof. Gustin. "And this results in a very intense pain which has very few treatment options."

Earlier this year, the team published a review looking into existing treatments for chronic neuropathic pain and found that current medications and non-pharmacological treatments show little response. The lack of pain management available can compromise the quality of care and quality of life for many patients with SCI, so there is a pressing need to explore potential new treatments.

Previous research, led by Prof. Gustin, published back in 2014 in the journal Pain, identified abnormal brain activity in the thalamus, a small structure located just above the brain stem, as a key neural signature of neuropathic pain following SCI.

Building on this knowledge, and continued research, one treatment began to emerge as a promising treatment.

Electroencephalographic (EEG) neurofeedback is based on the premise that the electroencephalographic pattern reflects the individuals' electrical brain signature. Using an EEG device, brain activity is measured hundreds of times per second to provide real-time feedback on the brain's state. As the brain learns to regulate the abnormal brainwaves through the neurofeedback, neural pathways can be reorganised.

EEG neurofeedback has primarily been used for the treatment of ADHD, anxiety and insomnia. Dr Hesam-Shariati recently published a meta-analysis, synthesising evidence from randomised controlled trials to evaluate the effectiveness of EEG neurofeedback for the treatment of chronic pain. The results suggested promising evidence of the analgesic effect of EEG neurofeedback, but that further studies are required in this novel area of research.

"The existing evidence supporting EEG neurofeedback for chronic pain is coming from small sample size studies. Conducting fully powered randomised controlled trials is necessary to obtain definitive results," says Dr Hesam-Shariati.

How does neurofeedback work?

The system developed by Prof. Gustin and Dr Hesam-Shariati consists of an easy-to-use, lightweight EEG headset that records electrical brain activity, paired with a tablet-based app that provides participants with clear instructions on how to regulate their brain activity via specially developed neurofeedback games.

"What is essential to PainWaive is that participants get visual feedback from these games," says Dr Hesam-Shariati. "The EEG headset measures electrical brain activity. The brainwaves are sent to our tablet-based app, processed using our codes, and then shown to the participant through the game, all in real-time."

Working with a large team, the researchers have developed four interactive games. One example begins with a rocket on earth. The user is told that the brain enters an optimal state – one able to regulate the abnormal brain signals that are highly linked to neuropathic pain – when the rocket begins shooting upwards, into the atmosphere.

Each system comes with instructions and recommended mental strategies to reach the 'optimal state' that the user is hoping to reach. "We advise participants to be mindful, be in the moment. To think about good memories, positive things, or even to imagine a happy place," says Dr Hesam-Shariati. "Because of the feedback element, participants can also develop their own mental strategies and see what works best for them."

The idea is that people with SCI can begin to apply these techniques outside of using PainWaive, and learn how to control their pain on a day-to-day basis.

"The brain is an extraordinary organ. By practicing EEG neurofeedback, the brain teaches itself to regulate the brainwaves and users are encouraged to then use these learned techniques and strategies day-to-day. So really, the aim for us is to decrease neuropathic pain daily, for long term," says Prof. Gustin.

Collaboration and development

The development of PainWaive involved feedback from consumers and stakeholders, whose input was instrumental in shaping its design and implementation.

"Dr Hesam-Shariati and I lead a large team," says Prof. Gustin. "We have an electrical engineer, a mechanical engineer, a software engineer, a clinical trial manager, a research assistant and multiple stakeholders."

And as well as working across such a multidisciplinary team, the PainWaive project has collaborated extensively with people who have nerve pain as a result of SCI, to help develop the intervention.

To begin, the team conducted a qualitative study to gain a deeper understanding of the community's needs, which indicated that this type of intervention would likely be well-received. Building on this, individuals affected by nerve pain from SCI played a key role in shaping the game design, contributing to the development of the headset, and testing both the software and hardware components through multiple prototypes.

Stuart Hurst, a consumer partner at NeuRA, experiences constant neuropathic pain in areas where he lacks sensation, and has consulted the team on the development of PainWaive. Five years ago, Stuart suffered a spinal cord injury after a near death motorbike accident in Nepal which left him paraplegic.