Get to know more about Mente Autism, the company behind it and the therapy we offer.
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Neurotech International Limited, is a medical device and solutions company incorporated in Australia, which operates through its Malta-based subsidiary, AAT Research.
Neurotech develops neuro-stimulation and neuro-diagnostic solutions delivered via the Mente platform, an innovative platform technology to enable medical practitioners to remotely monitor and play an active role in home-based therapies. Our product assists with the management of children with Autism Spectrum Disorder (ASD) with additional research and development commenced on a number of separate initiatives relating to tinnitus, anxiety, depression and epilepsy.
Mente Autism, is a portable, electroencephalographic (EEG) medical device for home use that uses closed-loop neurofeedback to help relax the minds of children with ASD. Its unique technology creates personalised auditory stimulation which uses power ratios of different brain wave activity that are present in children with ASD to normalise the connectivity pathways in the brain.
Mente Autism is a clinical-quality EEG device that uses patented neurofeedback technology to help children with autism. Designed for home use, Mente Autism helps relax the minds of children on the spectrum which in turns helps them to focus better and engage positively with their environment.
Mente Autism is an easy-to-use, effective neurofeedback system for safe home use by children with autism. It consists of a headband, an application (app) and a cloud component. Its unique technology creates “tailor-made” neurofeedback for the children who use it.
After each 40-minute morning therapy session, the system uploads the data registered after pressing synchronising during the session to the Cloud service via the Mente Autism App (using an Internet connection). Using this data, the Mente Autism cloud service generates a report that records and measures the child’s progress. Each session report can be viewed online or within the app. A number of online dashboards aimed at medical professionals and users enable deeper analysis and monitoring of the therapy.
Yes, Mente Autism holds the CE Medical certification. AAT is ISO 13485 certified.
FDA: Mente Autism is currently under FDA review.
CE Medical Certification: Mente Autism is classified as a Class IIa medical device and is regulated under the European Union Council Medical Device Directive 93/42/EEC. The CE marking for medical devices is awarded to companies that develop and manufacture medical devices with strict adherence to this directive. Mente Autism’s CE mark shows that the product complies with European health, safety and environmental protection legislation. Mente Autism medical devices can be branded with “CE 0426”, 0426 being the number of the notified body Italcert.
ISO 13485 Certified: Mente is ISO 13485 certified. This standard, enforced by the International Organization for Standardization, draws specific requirements and guidelines for a quality management system which manufacturers of medical devices can implement to provide products and services that consistently meet both customer and regulatory requirements.
Mente Autism is recommended for use by children who have a diagnosis of any condition within the Autism Spectrum Disorder, such as Asperger’s Syndrome and Classic Autism; and who have no history of hearing impairments. Ideally no co-morbidities should be present. Mente Autism is suitable for children between the ages of 3 and 12. Mente Autism therapy is NOT suitable for children with Rett’s Syndrome, ADHD, epilepsy or sporadic epileptic episodes, or Childhood Disintegrative Disorder (CDD). If the child is on medication, guardians should inform their authorised vendor or the company before trialling or purchasing the Mente Autism system. It is strongly suggested that a QEEG is carried out by the user’s medical professional prior to purchasing the system to determine whether Mente Autism is the correct therapy for the user. Mente Autism might be ineffective if the user has a low delta wave atypical of those diagnosed with ASD.
Ideally, Mente Autism sessions are held every morning for 40 minutes. The sessions should take place before that period of the day when the child/patient interacts socially and needs to be more calm – such as before starting school. This will allow the user to be calmer and more open to learning while under the prolonged effect of the morning session. The effect of the Mente Autism therapy wears off after the user sleeps, whether after an afternoon nap or a night’s sleep. Mente Autism should not be used more than once a day as the user might get headaches.
The user can use the Mente Autism system as a therapy throughout his or her lifetime. It is advised that the Mente Autism system is used every day with no or minimal interruptions. With time, the brain will learn to adapt to a more optimal brain frequency activity. This does not mean that the user will at some point no longer benefit from the device: constant use usually means continued progress. This progress is interrupted if the device is no longer used.
In terms of the device, it is important that this is properly taken care of, by avoiding damage to the device, regularly charging it and downloading any available software updates. The lifetime of the product is determined mainly by the battery life. The battery has a maximum number of charging and discharging cycles. It is therefore not advisable to charge Mente Autism after every session as this would reduce its lifetime. With a typical use of 40 minutes per session, a fully charged Mente Autism device should last between 3 to 4 sessions. The lifetime of the product is dependent on battery lifetime, which is 500 charge/discharge cycles. This results in approx. 5 years.
Use of Mente Autism should start between the ages of 3 and 12. It is recommended for use by children who have a diagnosis of any condition within the Autism Spectrum Disorder, such as Asperger’s Syndrome and Classic Autism; and who have no history of hearing impairments. Ideally no co-morbidities should be present. Since the most significant period of learning is throughout childhood, it is ideal for children to make use of the Mente Autism to relax their minds, thereby helping them be are more calm and focused.
Mente Autism produces a report after every session; this shows the brainwave frequency of the user before and after the session by means of a simple bar graph depicting the levels of the user’s Alpha, Beta, Delta and Theta brainwaves. Medical professionals can read the EEG results to determine how the system affected the user throughout the session. For trial purposes, the best way to learn which effects are due to Mente Autism is to stop all other therapies for four weeks and only use Mente Autism during that time. Thus the progress observed will be due only to Mente Autism.
Mente Autism uses the same principles as those used in advanced in-clinic neurofeedback sessions that use personalised and tailored auditory stimulation to respond to an individual’s own specific brain waves. Mente Autism does not rely on the simplified and much less effective systems that depend on undifferentiated music as utilised in some therapies. On the contrary, Mente Autism uses multiple biomarkers to ensure the most accurate readings thus enabling better interpretation of results by a medical professional.
Mente Autism produces tailor-made auditory stimulation signals, based on the fundamentals of neurofeedback (it uses a reward to stimuli basis). It has been designed to be used at home with minimal supervision by trained therapists, such as the patient’s parent or carer. Every session produces a daily report which is uploaded to a secure server and which allows for easy interpretation, understanding and tracking by the user and specialists from anywhere in the world.
Mente Autism does not use visual neurofeedback (such as those neurofeedback protocols utilised in hospitals for a number of conditions). This is because most autistic children (about 80%) of them have epileptic discharges during the night. By not using the visual cortex, Mente Autism accesses the desired brain area via a different route to avoid acting on such a sensitive area. The system Mente uses stimulates the auditory system (through neurofeedback) right up to the lower auditory brainstem. This way, the protocol we developed is able to measure exactly this process and create a neurofeedback loop to try to affect the brainwave level we want to target.
All the sessions can be done daily at home by the child, and a medical professional can check the results of the sessions via our online platform, in real time and from any part of the world, if parental/carer permission has been granted, or by using printed copies of the reports that the Mente system produces after each session.
Neurofeedback training is biofeedback induced by a neurological reading – in this case, EEG. During training, electrodes on the scalp measure electrical brain patterns – much like a physician listens to your heart from the surface of your skin. This data is then fed back to the participant in real time, usually through auditory or visual feedback, allowing for monitoring and adjustment of the mental state.
In Mente Autism, brainwave activity – in the form of alpha, beta, theta and delta waves – is recorded by the electrodes in the Mente Autism headband. Specialized software then converts the brain’s activity into a therapeutic auditory stimulation representation that influences brainwave levels. Following change, the brain can again be monitored thus creating a feedback closed loop. Children diagnosed within the Autism Spectrum Disorder (ASD) spectrum tend to have lower than average alpha and beta levels and higher delta and theta activity levels.
Following wave recordings, the binaural beats are created so as to inversely present back to the patient the required signals to induce the brain to work in a desirable pattern. Mente Autism neurofeedback therefore helps promote alpha and beta brain waves whilst reducing delta ones. Changes are short-lived at first, but then gradually become more enduring, making neurofeedback an effective form of therapy for ASD.
The word binaural means “having or relating to two ears”. The sensation of auditory stimulation occurs when two sounds of nearly similar frequencies are presented one to each ear with stereo headphones or speakers. The brain integrates the two signals, producing a sensation of a third sound called the binaural beat or neurofeedback. Thus, if 210Hz pulses into one ear and 200Hz into the other, the brain will process the two sounds into a 10Hz frequency, namely the difference between the two frequencies.
The binaural beats then cause the brainwaves to begin resonating in tune with the beat. With Mente Autism, auditory stimulation frequencies are produced according to the brainwave reading of the EEG. Children diagnosed with Autism Spectrum Disorder (ASD) tend to have lower alpha and beta waves, which are the waveforms respectively associated with focus and mental activity, and higher delta waves.
Delta and theta brainwaves are usually present in high levels during sleep; but in people with ASD, delta and theta waves are abnormally high and peak constantly even when they are awake. By creating auditory stimulation at a particular frequency, the brain is triggered to resonate at that same frequency, automatically inducing brain activity in the respective waveform spectrum. Alpha and beta waves can therefore be promoted whilst delta waves are suppressed. To listen to a sample of the sound, please click here.
In people without ASD, Delta Δ and Theta ϑ brainwaves are usually present in high levels during sleep, while Alpha α and Beta β waves are associated with focusing and activity. This is not so in people with ASD, whose Delta and Theta waves tend to be abnormally high and peak constantly, even when they are awake. The therapy sessions are intended to promote the levels of α and β waves and suppress the levels of Δ and ϑ waves so that the child feels more aware, focused and calm.
Via sensors on the scalp, Mente Autism records patterns of brain activity. The combination of electrical activity of the brain is commonly called a ‘brainwave pattern’ because of its cyclic ‘wave-like’ nature. These brainwaves are generally classified according to their frequency, amplitude and shape. Among the basic waveforms are the alpha, beta, delta and theta rhythms. These basic rhythms are associated with different mental states.
Alpha waves occur at a frequency of 8 to 12 cycles per second in a regular rhythm. In general, they are present when you are awake, relaxed and have your eyes closed. Usually they disappear when you open your eyes or start mentally concentrating.
Beta waves occur at a frequency of 13 to 30 cycles per second. Normally beta rhythms occur in individuals who are alert and attentive to external stimuli or are exerting specific mental effort. Beta waves are also present during tension, agitation and anxiety and paradoxically also occur during deep sleep when the eyes switch back and forth.
Delta waves occur at a frequency of 0.5 to 3.5 cycles per second. They are generally prominent during sleep or when there is unconscious activity. As people move from lighter to deeper stages of sleep, the occurrence of alpha waves diminishes and is gradually replaced by the lower frequency delta waves.
Theta waves occur at a frequency of 4 to 8 cycles per second. This particular frequency range is involved in daydreaming and sleep. They are connection with feeling deep and raw emotions. Too much theta activity may make people prone to bouts of depression, ADHD and inattentiveness. Too little can lead to anxiety, poor emotional awareness and stress.
Contrary to these normal brain wave patterns, individuals diagnosed with Autism Spectrum Disorder (ASD) tend to have lower alpha waveform peak counts and lower beta peak counts; they also have higher levels of delta waves than average, meaning that delta waves continue to peak even when the participant is awake. This leads to reduced levels of activity and concentration.
The main aim of Mente Autism is therefore to detect and modify slow brain wave activity by suppressing delta waves and promoting alpha and beta ones. This leads to increased levels of alertness and concentration enabling the child to engage more mentally and socially.
No. Mente Autism is non-invasive and each session trains the brain to become more focused and concentrated, resulting in calmer communication and interaction levels observed in the users. The sessions will not get in the way of other therapies the child might be undergoing; and could actually be beneficial.
The appearance of the beneficial effects of Mente Autism is unique to each user. Every individual experiences a personalized and different effect; however, as a baseline, an adaptation process of four to eight weeks of usage is needed prior to seeing a beneficial effect. This adaptation process could take less or longer depending on various aspects, including severity of the medical condition, age and plasticity of the brain.
The difference between Mente Autism and other forms of therapy is that, during the session, Mente Autism allows the patients to freely carry on with their activities. Thus there is no need to make your child sit still – all that is required is that he/she does not take part in any activity that involves hearing, such as listening to music or watching television with the sound on, as this would interfere with the benefits of the session. Mente Autism only requires a 3G or hotspot connection at the start of every session and to upload session data to the Mente server. During the session the child can move around the house freely, although jumping around should be avoided.
Yes, it is actually highly recommended that the user engages in normal activities rather than leaving the brain idle. This will generate activity readings in the Mente Autism software and help train the brain to be more focused, concentrated and responsive. Research suggests that the session is more successful if the patient is freely left to continue with other tasks uninterrupted (even if that includes playing, etc. although jumping around should be avoided). Activities that require hearing will, however, interrupt the child’s responsiveness to the session and should therefore be avoided.
The neurofeedback emitted from the software is in the form of auditory simulation that is played to the user, modifying the volume. The volume varies from person to person and from session to session since they are a real-time aural representation of the user’s brain waves during each session. The change in volume results in neurofeedback signals that stimulate and ‘teach’ the brain to motivate the brain waves that are lacking, namely ‘Alpha’ and ‘Beta’ waves, to achieve normal levels, while moderating the ‘Delta’ and ‘Theta’ levels – eventually making the user more responsive, communicative, focused and interactive. This is a sample of the sound.
In our research, we have not come across patients who suffered from unforeseen side effects as long as the therapy is used according to instructions, for example, used in the morning. Nonetheless, the product should not be used more than once a day, as this may give the user a headache.
The idea behind the system is for the patient to receive audible feedback that is specific to him/her, i.e., the therapeutic feedback played during the session is tailor-made for the user and is a central part of the treatment. Removing or limiting other sounds will enable the session to produce a far better result. The earphones provided should be used.
No. Since the therapy session is tailor-made for the user, anyone who happens to listen to the sounds would not be affected. Nonetheless, this should not be an issue as we advise that the child listens to the Mente Autism neurofeedback wearing the earphones provided and with minimal audio interference from the surrounding environment.
For the system to be operational, you need the Mente Autism headband, along with the Mente Autism software (downloaded as an application, or app) on a smartphone or tablet, along with the Mente Autism earphones provided connected to the headband.
If stopped for a day, the effects are minimal. However, if the therapy sessions are stopped for longer periods the child will regress.
The benefits of each session wear off when the child sleeps as the brainwaves re-sets during sleep.
From parent testimonials, the following improvements were noticed generally within first 4 to 8 weeks; naturally, these changes and their extent varies from child to child:
-Longer concentration spans and more attention
-Increased calmness and reduction in tantrums
-Longer periods of contentedness
-Increased shows of affection
-better acceptance of peers and siblings
-Increased respect towards parents
-Increased vocabulary with better communication
-Increase in decision-making capabilities
-Better academic result
All data is stored in our secure Mente Autism cloud system after the user has given their approval. Patients have full access to that data and the reports that are generated daily. Storing the data securely in the cloud has two benefits. First, even if the device used for the “daily session” is lost, stolen or broken, the data of the child can be recovered (using a secure card with a special pin and serial number) on another device. In that way, all previous information related to the usage and progress of the child would be recoverable. Second, the data and reports can be accessed from anywhere and using any device with an internet connection. At the same time, all patient data is stored separately from the customer’s personal data. This ensures that even if the session data is not identifiable unless access using customer credentials. Passwords are stored on a separate server.
We take pride in keeping a close look on this aspect. The FDA and CE medical processes themselves are quite strict about this, and we fulfil our duties with regular audits. We do offer the option for people using our devices to allow us to add their children on a “monitoring programme” (optional). The first study we published was following 8 children for 8 months, and the results we published in a very well placed medical journal have been extremely positive.
While Mente Autism is not a cure for autism, it has been shown to reduce the symptoms of autism, making a material difference to the user. It does this by actively reducing the user’s delta wave profile, which tends to be abnormally high in people with autism. Regular 40-minute use every day, first thing in the morning, is generally sufficient to generate (within a four- to eight-week period) a marked improvement in symptoms of children on the autism spectrum.
Fluctuations (minor ups and downs) may be noted in all four frequency bands – this is perfectly normal and part of therapy protocol. These fluctuations may be a sign of adaptation and consolidation within the user’s brain towards the therapy. Due to this, therapy effectiveness cannot be gauged over one session but needs to take place over a period of time.
Mente Autism is designed for home use but it is also a clinical-quality EEG device using state-of-the-art hardware and software to provide an effective neurofeedback system.
Mente Autism is a portable system. Its 4-channel EEG headband houses five highly sensitive electrodes which record electroencephalographic (EEG) potentials from the scalp in real time. This EEG signal is amplified, filtered and processed to create a therapeutic, auditory stimulation in real time. Changes in potentials are graphically displayed via the Mente Autism app (if connected via a 3G or hotspot connection).
Five top-of-the-line sensors are used to ensure optimum quality EEG recordings. The positioning and type of the sensor on the headband (one type to be worn on the forehead, one to penetrate hair and reach the scalp at the back of the head) are such that readings of the four brain waves are accurate, the signal is more stable and resolution is much better. The sensors use the latest lower impedance electrodes and generate far less noise. The sensors have passed the ISO 10993-1 biocompatibility test.
• Dry surface to user’s skin
• Consists of a conductive membrane behind which is electrode gel typically used in clinical EEG systems
• Cushioned sensor surface conforms to irregular body surfaces better than metal discs
• Low-noise conduction between body and sensor
• Stable Ag/AgCl Interface
• Impedance 10 – 100 K on unprepared skin
• Novel shape optimized for hair penetration and scalp contact
• Special silver coating imparts optimal conductivity to the sensor’s surface for the best possible signal transduction
• Flexible material safely flattens under pressure – no hard metal pins
• Flexible legs slide under hair strands for scalp contact
• Impedance 100 – 2000 K on unprepared skin
Through accurate EEG recordings, with high coherence levels for better source localization, Mente Autism analyses abnormal brainwave activity in children with autism. This abnormality is
characterized by excessively high Theta and Delta wave levels in the fronto-temporal areas of the brain. Using this neurological information, Mente Autism creates an inverse feedback signal to the brain through the patient’s auditory system.
Mente Autism uses the auditory cortex within the brain to target surrounding areas, such as the thalamus and the superior temporal gyrus. These areas are accessible through the system’s innovative auditory stimulation techniques, using the specificity provided by neurofeedback. The auditory stimulation created aims to supress excessive Delta and Theta activity while promoting and stabilizing Alpha and Beta rhythms.
Electroencephalography (EEG) is a proven technique to record brain activities in natural settings. A problem often encountered is that EEG signals may be contaminated by ocular artefacts such as eye blink activities. To achieve satisfactory cleaning of the raw EEG signal from eye-blink artefacts, Mente Autism uses a series of algorithms that are applied in real-time, are window-based and conform with already-established methods of sampling and filtering.
Throughout the session, the Mente Autism device constantly checks that each sensor is correctly positioned with optimal connection with the head. On the app, the parent or carer can view the status of each sensor. A warning is issued via the app if there is an issue and the session is paused until the sensors’ position is fixed. If Mente Autism is not connected to a tablet or phone and a sensor is out of place, the session will stop and the LED light on the headband will turn orange. If this happens, parents / carers can reconnect to the app to check that all sensors are properly positioned. Parents /carers also have control over the volume of the device (sound check), battery monitoring and LED notifications which are fully explained in the User Manual.
Medical professionals who are authorised by the user’s parents or guardians have remote access to a dashboard from where they can observe the users’ daily performance and overall progress. Medical professionals can download high-definition EEG results.
Info-graphical statistics about Alpha, Beta, Delta and Theta brainwave levels are presented in a report generated after each therapy session. Medical professionals can also download raw neurological data.
Furthermore, medical professionals can remotely upload routine clinical data into the system to fine-tune the home-based therapy.
To determine the Delta and Theta wave levels and suitability of the therapy, it is recommended that a quantitative EEG (QEEG) is carried out by a medical professional prior to initial Mente Autism usage to define whether Mente Autism is indicated for the child’s use. It is recommended that Mente Autism use starts between the ages of 3 and 12 years of age. Mente Autism is not suitable for children who have a history of hearing impairment. It may not be suitable for children on certain medications or if comorbid conditions are present.
The earphones provided in the product box have been extensively tested with Mente Autism. It is our recommendation that these are used for the therapy.