Perth-based medical solutions company Neurotech International (ASX: NTI) has confirmed its Mente Autism device specifically developed for children with autism is capable of producing significant positive changes in brain activity, balance and behaviour.
The confirmation follows the completion of a US clinical trial which aimed to ascertain the consequences of Mente Autism neurofeedback treatment on children with autism spectrum disorder.
Conducted over 12 weeks of home-based therapy, the trial was a randomised-controlled, double-blind investigation, which compared Mente Autism with a control (or sham) device. Parents and medical staff were completely unaware of which group each child was participating in.
Key findings from the group using the device showed significant reductions in the brain wave frequency bands of interest (delta, beta and high beta) which are typically abnormally-high in children with autism; as well as improved balance with eyes open rather than closed, which is the opposite effect experienced by autistic children.
The trial also showed Mente Autism to have a positive effect on autistic behaviours and improvements in social skills and communication.
Importantly, the group using the sham device showed little change across the board.
Neurotech chief executive officer Wolfgang Storf said the positive trial results “provide a strong basis” for the company to progress towards a Food and Drug Administration submission, targeted for late 2018.
“To have the parents of autistic children say their social interaction and communication has improved post-therapy, and have this supported by the science, are key outcomes we have targeted with Mente Autism from day one,” he said.
“We hope this will raise awareness about neurofeedback as one of the tools to help parents of children with autism, that is non-invasive and doesn’t involve drugs.”
Safe and accessible autism therapy
Mente Autism was developed as a non-invasive and safe therapy to help autistic children relax their minds, which, in turn, helps them focus better and engage positively with their environment.
It was launched in 2016 as the world’s first clinical-quality electroencephalogram (EEG) device designed to safely manage the condition within the confines of a patient’s home, potentially eliminating the considerable cost, time and effort involved in attending autism therapy in clinical environments.
Marketed as an accessible and easy-to-use neurofeedback system, Mente Autism consists of a headband, a software application and a cloud component.
Children wear the headband for 40-minutes of morning therapy each day, after which parents upload the neurofeedback data collected and the Mente Autism cloud service generates an online report which measures the child’s progress.
Neurotech said manufacturing of the next batch of Mente Autism devices is “well underway”, with the first units expected to be ready by month end and initial shipments commencing in August.
At midday, Neurotech shares were up 6.45% to A$0.165.