Periodic Reporting for period 1 - Brainhero – Embracing Neurodiversity (Science-based Brain Training at the comfort of your home – medically certified)
Periodo di rendicontazione: 2023-04-03 al 2024-04-02
Brainhero GmbH is an Austria-based clinical-stage neurotechnology company. The company is focused on developing and commercializing digital treatments for neurodevelopmental diseases, focusing predominately on the two most common pediatric neurological disorders, Autism Spectrum Disorders (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD).
Brainhero conducts studies to evaluate the clinical benefits for children with ASD or ADHD using a digital application for cognitive-behavioral training. The application (Brainhero App®) uses the brain's electrical signals to control video games (neurofeedback). For that, Brainhero provides a portable medical device that collects brain activity and designs training regimens to specifically alleviate symptoms present in ASD or ADHD patients (e.g. alterations in focus, abnormal motor activity, frustration management, etc.).
Brainhero developed the program MUsicAUT: A personalized at-home neurofeedback compared with placebo in children with autism spectrum disorders: a European, randomized triple-blind trial. This is a clinical trial (Phase II/III) to evaluate which changes in the brain are associated with positive clinical effects in patients using the Brainhero App.
With the outcome of the clinical trials, Brainhero will identify critical neurofeedback signals in neuropediatric patients (e.g. individual brain areas and particular electrical patterns) to offer personalized therapies (i.e. training regimens of adapted duration and repetitions). The goal is to have a patient-centered therapeutic solution to treat specific ADS and ADHD symptoms, thus offering a tailored solution to the wide population treated with generic pharmacological or behavioral/social interventions.
Ultimately, Brainhero proposes a digital incursion in treating neuropsychological traits to include neurodivergent patients in our modern society.
For that, we bring the safety of a medical device at home and involve the parent or tutor in the intervention, thereby enhancing the effectiveness of the treatment (e.g. finishing the therapy).
Brainhero conducts studies to evaluate the clinical benefits for children with ASD or ADHD using a digital application for cognitive-behavioral training. The application (Brainhero App®) uses the brain's electrical signals to control video games (neurofeedback). For that, Brainhero provides a portable medical device that collects brain activity and designs training regimens to specifically alleviate symptoms present in ASD or ADHD patients (e.g. alterations in focus, abnormal motor activity, frustration management, etc.).
Brainhero developed the program MUsicAUT: A personalized at-home neurofeedback compared with placebo in children with autism spectrum disorders: a European, randomized triple-blind trial. This is a clinical trial (Phase II/III) to evaluate which changes in the brain are associated with positive clinical effects in patients using the Brainhero App.
With the outcome of the clinical trials, Brainhero will identify critical neurofeedback signals in neuropediatric patients (e.g. individual brain areas and particular electrical patterns) to offer personalized therapies (i.e. training regimens of adapted duration and repetitions). The goal is to have a patient-centered therapeutic solution to treat specific ADS and ADHD symptoms, thus offering a tailored solution to the wide population treated with generic pharmacological or behavioral/social interventions.
Ultimately, Brainhero proposes a digital incursion in treating neuropsychological traits to include neurodivergent patients in our modern society.
For that, we bring the safety of a medical device at home and involve the parent or tutor in the intervention, thereby enhancing the effectiveness of the treatment (e.g. finishing the therapy).
Since April 2023, we have achievements in the following three aspects:
REGULATORY COMPLIANCE:
1. We have renovated the International Organization for Standardization (ISO) with a focus on medical devices (13485) on 10th January 2024 (valid starting on 1st April).
TECHNOLOGICAL DEVELOPMENT:
1. We started expanding our software development kit (SDK) to allow third-party applications (e.g. Encevis https://www.encevis.com/) to connect to our home-based electroencephalographic acquisition system (Orbit® or Atlas®).
2. In addition, we prototyped the Brainhero Gameshop, a platform for easy and fast game prototyping, testing, and deployment that will allow our patients to train with similar neuroplasticity protocols using different interfaces (i.e. games).
3. We also optimize the ear clip material delivered with our portable EEG (Orbit®) to obtain durable signal acquisition while enhancing more comfort for the patients while training.
CLINICAL INVESTIGATION:
1. We submitted the Clinical Evaluation Plan and the Clinical Evaluation Report for auditing compliance with the MDR 2017/745 (third revision) on 31 January 2024. The answer was delivered on the 4th of March, 2025, encouraging us to start collecting clinical data and expand the intended use of our medical device to specific patient populations. A date for the next revision was suggested for November 2024.
2. In addition, we started the psychometric analysis of clinical symptoms. To date (19 March., 2024), we found that for Autism, 100% of the patients reported 1) a better understanding of cause-effect relationships and 2) Improvements in accepting suggestions and solutions from others (e.g. parents). For Attention/Deficit-Hyperactivity Disorders (ADHD), 100% of the patients reported 1) Enhancement in concentration and 2) a better ability to remember times and locations (e.g. do not lose things)
REGULATORY COMPLIANCE:
1. We have renovated the International Organization for Standardization (ISO) with a focus on medical devices (13485) on 10th January 2024 (valid starting on 1st April).
TECHNOLOGICAL DEVELOPMENT:
1. We started expanding our software development kit (SDK) to allow third-party applications (e.g. Encevis https://www.encevis.com/) to connect to our home-based electroencephalographic acquisition system (Orbit® or Atlas®).
2. In addition, we prototyped the Brainhero Gameshop, a platform for easy and fast game prototyping, testing, and deployment that will allow our patients to train with similar neuroplasticity protocols using different interfaces (i.e. games).
3. We also optimize the ear clip material delivered with our portable EEG (Orbit®) to obtain durable signal acquisition while enhancing more comfort for the patients while training.
CLINICAL INVESTIGATION:
1. We submitted the Clinical Evaluation Plan and the Clinical Evaluation Report for auditing compliance with the MDR 2017/745 (third revision) on 31 January 2024. The answer was delivered on the 4th of March, 2025, encouraging us to start collecting clinical data and expand the intended use of our medical device to specific patient populations. A date for the next revision was suggested for November 2024.
2. In addition, we started the psychometric analysis of clinical symptoms. To date (19 March., 2024), we found that for Autism, 100% of the patients reported 1) a better understanding of cause-effect relationships and 2) Improvements in accepting suggestions and solutions from others (e.g. parents). For Attention/Deficit-Hyperactivity Disorders (ADHD), 100% of the patients reported 1) Enhancement in concentration and 2) a better ability to remember times and locations (e.g. do not lose things)
Brainhero was founded to help parents and families in the integration of children with autism spectrum disorders. However, in its development, it has expanded to implement the latest neurotechnologies to solve a wide range of psychological traits, thus providing a future tool to treat altered states as well as symptoms in neurodivergent patients. We have now started collecting and analyzing neuropsychological traits in non-diagnosed patients and the general population with the goal of providing a data-driven therapy that will be tailored to alleviate individual symptoms.
In doing so, we are planning to offer a clinical-grade tool (i.e. a class IIa device) according to the European Union (EU) Medical Device Regulation (MDR 2017/745) to apply scientifically proven training therapies. Our current training regimen uses neurofeedback technology to apply brain neuroplasticity protocols that induce synaptic changes (i.e. alterations in the connections between nerve cells). We started exploring different plasticity protocols and their relation with the symptomatological alleviation of concrete symptoms that appear in Autism Spectrum Disorders (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD).
Finally, when applying neuroplasticity-based training, we also started to test the latest software development technologies that combine Augmented Reality (AR) and Virtual Reality (VR) to provide a better patient experience. This is part of our Research and Development (R&D) and, therefore, more speculative.
Overall, all those improvements have led to a drop-out rate (i.e. percentage of patients leaving our therapy) of 11.5% to date (22 February 2024). This is a result way beyond the state of the art since the World Health Organization (WHO) reported that since 2003, 50% of the patients have failed to adhere to their therapeutic regimens
In doing so, we are planning to offer a clinical-grade tool (i.e. a class IIa device) according to the European Union (EU) Medical Device Regulation (MDR 2017/745) to apply scientifically proven training therapies. Our current training regimen uses neurofeedback technology to apply brain neuroplasticity protocols that induce synaptic changes (i.e. alterations in the connections between nerve cells). We started exploring different plasticity protocols and their relation with the symptomatological alleviation of concrete symptoms that appear in Autism Spectrum Disorders (ASD) and Attention-Deficit/Hyperactivity Disorder (ADHD).
Finally, when applying neuroplasticity-based training, we also started to test the latest software development technologies that combine Augmented Reality (AR) and Virtual Reality (VR) to provide a better patient experience. This is part of our Research and Development (R&D) and, therefore, more speculative.
Overall, all those improvements have led to a drop-out rate (i.e. percentage of patients leaving our therapy) of 11.5% to date (22 February 2024). This is a result way beyond the state of the art since the World Health Organization (WHO) reported that since 2003, 50% of the patients have failed to adhere to their therapeutic regimens