Community Research and Development Information Service - CORDIS

H2020

NEWROFEED Report Summary

Project ID: 684809

Periodic Reporting for period 2 - NEWROFEED (Personalized medical device for the diagnosis and treatment of ADHD based on EEG biomarkers and Neurofeedback Training)

Reporting period: 2016-10-01 to 2017-09-30

Summary of the context and overall objectives of the project

Attention Deficit Hyperactivity Disorder (ADHD) is a chronic, debilitating disorder usually diagnosed during childhood impacting negatively many aspects of patients’ lives including: academic achievements, social skills, perception of self-worth and leads to strained parent-child relationships.
It is a major public health issue. The cost of illness has been estimated as being as high as €7,000 per patient per year in the UK (Telford C. et al. - 2012) and the prevalence of the condition in Europe is estimated at 5% of the child population. In other words, 4 million EU children are likely to be suffering from ADHD.
The most common treatment for ADHD is a form of psychoactive medication, and in many cases, methylphenidate (MPH), a molecule of the amphetamine family. While these drugs do have a positive impact, leading to short-term adaptation of the child’s behavior, they are purely symptomatic. They also have significant side effects, impacting sleep, appetite and sometimes the personality of the child through affective blunting and reduced creativity. These drugs are generally negatively perceived and that perception impacts adherence negatively (Berger I, Dor T, Nevo Y, Goldzweig G. -2008).
It is obvious that there is a need for innovative, drug-free treatments for ADHD. We believe there is an alternative: neurofeedback, a methodology to “rewire” the brain that was conceptualized in France as early as the 1930s (Fressard and Durup - 1935) and later developed in the US from the 1960s onwards (Stermann - 1966). It is a self-paced neuromodulation technique that uses the signals from the brain, collected in real-time using a safe, non-invasive measurement device called electroencephalography (EEG), to help the patient train brain functions and normalize its activity to a healthy range of functioning. It has been associated with improved outcomes in ADHD children in many controlled studies, which recent meta-analysis pooling those positive results into stronger level of evidence (Micoulaud-Franchi 2013). Some studies have demonstrated that the care delivered via neurofeedback had long-lasting effects: children treated for a few months with NFB remained free of the symptoms 6 months even after having ceased the treatment (Steiner et al.- 2014), a major departure from the symptomic-only impact of drugs.
Two main issues have hindered the deployment of neurofeedback as a large-scale treatment for ADHD: first of all, the large heterogeneity of technical and methodological implementations in existing trials; second, the lack of a standardized technical implementation for the automated delivery of neurofeedback.
We believe those two issues can now be resolved: research in neurofeedback in ADHD has made tremendous progress in the past few years and is focusing increasingly on a limited number of brainwaves frequencies and methods with demonstrated efficacy. Also, recent breakthroughs in EEG hardware and real-time software are finally enabling the development of a fully automated neurofeedback device that would be user-friendly and robust enough to be used in the home by the patients and their families themselves, after medical prescription.
This is the device we set out to develop and demonstrate through the NEWROFEED project.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

We are now 80% through the project, and have made tremendous progress in the first two years of its execution.
In the first year of NEWROFEED, our focus was to finalize the system necessary to start enrolling patient in the Randomized Clinical Trial necessary for its clinical demonstration. The three main technical tasks and milestones for the first year of the project were achieved:
·We finalized the specifications of the software and hardware elements of the system tested as part of the clinical trial, called ADHD@HOME.
·We finalized the implementation of the optimal hardware solution for ADHD@Home.
·We developed the software stack necessary for the real-time extraction of biomarkers and delivered on time a complete, validated, innovative solution, including the front-end sitting on the tablet as well as the back-end sitting on our servers, to the clinicians leading our clinical trial.
·We designed the study protocol necessary to prove the safety and efficacy of our solution in tandem with our Key Opinion Leaders and got the study approved in a number of European countries.
We reached a major milestone right before the end of the first year of NEWROFEED when the first patient was enrolled on August 31, 2016 in one of the French investigation centers.
The second year of the project was focused on three main tasks:
·Managing the enrolment of patients in NEWROFEED and supporting our investigation centers with training and technical and clinical support, while ensuring patient safety;
·Incorporating the feedback from the patients into an optimized version of our neurofeedback platform that we can take to market;
·Starting dissemination and commercialization activities activities, and, in particular, obtain CE marking for our device under the European Directive for medical devices, 93/42/EEC.
We had our share of challenges in Year 2 but are happy to report that our main goals have been reached and we are excited to be nearing the point at which we will be able to start commercializing our technology. In particular, in a major breakthrough, we received certification for our ADHD product a few days after the end of Year 2: this makes Mensia the only company in Europe with a market-approved digital therapy. This means we will start the commercialization of our technology, both directly and via distributors, within a few weeks.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

One, we have demonstrated that research-grade EEG acquisition in the home, with an affordable device, and with support from lightly trained parents is possible. This was considered a major challenge by the EEG community at large when we started, but, at this point, we can report that we have 94% equivalence in data quality between sessions recorded at home and sessions recorded in the clinic with the help of a trained specialist.
Second, we initially met skepticism when suggesting that ADHD children would comply on their own with the schedule and efforts required by neurofeedback training in the absence of a therapist. We can now report that we have 90% of our patients who use the system at least twice a week, a very good level of compliance.
Finally, the first 50 patients who have gone through the trial on the neurofeedback arm have demonstrated the safety profile of our solution, with just one sixth of the side effects reported in the drug arm.
In terms of impact, the market has continued to grow at its usual, global pace of 8+%, both in Europe and the US, reaching $11bn in 2015 (source: IMS Health) for ADHD drugs. ADHD is still the number one market for drugs in child psychiatry in the world.
The European patient associations we have spoken to have confirmed the view that end users are looking for alternative to pharmacological treatment and would be willing to pay out of their own pockets a large part of the cost of the device while we seek reimbursement.
Physicians are looking for alternatives as well: our proprietary research has shown that 90%+ of the health care professionals (all physicians: child psychiatrists, neuro-pediatricians…) we queried declared they would use our product as first line treatment for ADHD children if its equivalence versus MPH and curative effects were proven.

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