In 2013, the BRAIN e-NOVATION joint laboratory has brought together the medical expertise of the Brain & Spine Institute (ICM) and the expertise of GENIOUS Systèmes in Digital and New Technologies. The BRAIN e-NOVATION Lab aims to create innovative tools dedicated to therapists and patients, and classified as Digital Medical Devices (MD).
Within the BRAIN e-NOVATION Lab, the roadmap of GENIOUS and ICM is to design innovative uses in Health, to assess their clinical validity, and to bring them onto the tomorrow’s digital MD market through the online GENIOUS platform, www.curapy.com. Indeed, since proven clinical efficacy is achieved in a target patients’ population, a multilanguage digital MD, available online, has the same worldwide dissemination potential as a drug, whereas the investments will be much higher to develop a new drug than a digital MD.
The ICM, located in the Pitié-Salpêtrière hospital in Paris, in which the “Nervous System Diseases Pole”, is gathering all the patients with a neurological disease, and is a research center of international dimensions without equivalent in the world, dedicated to Parkinson’s disease, Alzheimer’s disease, psychiatric disorders, etc.
Since 2011, GENIOUS Healthcare, the e-Health subsidiary of GENIOUS Systèmes, has developed a cutting edge expertise in designing and developing therapeutic videogames tailored to neuropsychiatric diseases and classified as Digital MD. GENIOUS has been currently managing and carrying out 6 R&D projects in close partnerships with academic laboratories.
Thanks to the complimentary in expertise of each partners, and as stated in the initial roadmap, the first research works carried out within the BRAIN e-NOVATION lab have lead up to innovative solution development to efficaciously treat the gait and balance disorders. To achieve this goal, the joint lab has developed a therapeutic tool dedicated to patients with Parkinson’s disease (PD). The 2013 roadmap has been applied step by step to answer this issue. The TOAP RUN therapeutic videogame has been developed based on the PD patients’ needs (step 1, 2013) to rehabilitate their gait and balance disorders (step 2, 2013-2015).
The acceptability and feasibility of the game were first tested in 10 severely affected PD patients, in an open label pilot study with 18 training sessions using the game performed at the hospital (step 3, 2015-2016). This first study shows that videogame rehabilitation is feasible and well accepted in those disabled patients, and we observed also a significant reduction in the severity of gait and balance disorders, with a disappearance of falls in 7 out 10 patients and an objective improvement in gait performance during the all duration of the training period, with some sustained benefit three months after the last training session (INSERM C15-12; Nuic et al, 2018).
The efficacy of the game TOAP RUN is now tested in 50 PD patients with gait and balance disorders, in a randomized controlled parallel group study, performed both in France and in Netherlands (sponsor INSERM C17-07), with financial support of the European Program EUROSTARS. For this purpose, a new version has been developed to enable patients to access a home-based gaming/rehabilitation (step 4, 2016-2019). Within the same period, the game TOAP RUN has become MD.
In the continuity of this first LabCom implementation, other research programs are carrying out to offer such tools in other neurologic or psychiatric diseases. Thus, with the continuation of BRAIN e-NOVATION, a unique opportunity is being offered to disseminate the first therapeutic solution whose clinical validity is close, and to explore new solutions in the neuropsychiatric diseases.
Madame Marie-Laure WELTER (Institut du Cerveau et de la Moëlle épinière)
The author of this summary is the project coordinator, who is responsible for the content of this summary. The ANR declines any responsibility as for its contents.
ICM Institut du Cerveau et de la Moëlle épinière
Help of the ANR 100,000 euros
Beginning and duration of the scientific project: August 2019 - 18 Months