Community Research and Development Information Service - CORDIS


NEWROFEED Report Summary

Project ID: 684809

Periodic Reporting for period 1 - NEWROFEED (Personalized medical device for the diagnosis and treatment of ADHD based on EEG biomarkers and Neurofeedback Training)

Reporting period: 2015-10-01 to 2016-09-30

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. There is an alternative: neurofeedback, a methodology to “rewire” the brain that was invented in France in 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 technique 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 symptom-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 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 without a doctor or a therapist present.

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 halfway through the project, and its execution is generally on time and on budget, having reached a major milestone by starting to include patients as part of our RCT by August 31, 2016. The three main tasks and milestones for the first year of the project were achieved. We are confident the most important goals of the project will be met before its scheduled completion in September of 2017.
In the first three months of the project:
• 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, in partnership with a manufacturer of research-grade EEG systems. Together, we were able to deliver a fully tested and functional hardware environment in time for the start of the clinical trial.
• We developed the software stack necessary for the real-time extraction of biomarkers. We 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 and neurofeedback specialists whose experience we wanted to tap to ensure we had the best chances of success for our RCT. This solution is unique and a world first.
In terms of clinical demonstration, in less than a year, we were able to:
• Appoint the Scientific Committee of the study, including worldwide leaders in the field of ADHD and neurofeedback;
• Select the initial 10 investigation centers in 5 European countries based on their ability to recruit promptly at a reasonable costs;
• Design and write the study protocol and corresponding CRF in agreement with our Key Opinion Leaders;
• Complete the technical dossier of the ADHD@Home device for clearance of the full solution for RCT in 5 countries;
• Submit it to regulatory bodies in France, Germany, Spain, Belgium and Switzerland and get clearances in a number of countries.

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)

A number of results are already notable, halfway through this project.

One, we have demonstrated that research-grade EEG acquisition in the home, with an affordable device, and with support from only lightly trained parents is possible. This was considered a major challenge by the EEG community at large when we started and we are happy to report that the software features we put forward to cope with the inherent limitations of the hardware made it possible.

Likewise, we have initially met skepticism when suggesting that ADHD children would comply on their own with the intense training program required by neurofeedback training, particularly in the absence of the impetus of therapist. The first inclusions in the NEWROFEED trial are unfolding smoothly with that respect and dropout rates remain within expected boundaries.

In terms of impact, if anything, since the drafting of our grant submission in March of 2015, its potential impact has grown. 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 safe as the number one market for drugs in child psychiatry in the world.

We have also been able to deepen our analysis of the needs of the various stakeholders of the condition. 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.

Market research we have conducted in France in 2016 has also confirmed the fact that 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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