University of Milan, NEWRONIKA S.R.L., HUMANITAS MIRASOLE S.P.A., Fondazione IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO
Lesions of the cerebral motor areas, especially the primary motor cortex, seriously compromise voluntary movement and language, with little hope of recovery. In most cases, these injuries are due to tumours in the central nervous system, trauma and/or stroke. Electromagnetic stimulation has emerged in recent years as a viable neuro-rehabilitation therapy.
The project will produce a biomedical device for brain stimulation to be applied in the field of neurorehabilitation in patients with diseases of the central nervous system that affect voluntary motor skills.
The device will be able to administer chronic stimulation protocols that promote the reorganisation of the motor areas affected by vascular or tumoral lesions allowing at least a partial but significant improvement in the functional autonomy of patients, significantly reducing healthcare costs for their care.
The fundamental components of the device are the electrodes that have radically innovative features in terms of ergonomics and effectiveness in neuromodulation, allowing an optimum adaptation to the cortical surface and thus ensuring precision and stability in the administration of electrical pulses.
Such electrodes are based on the use of a proprietary Wise technology that allows the production of nanostructured metal layers on biocompatible silicone that are soft, highly deformable and that guarantee a great versatility in the production of shapes and sizes of the electrodes. The design uses parallel non-invasive stimulation therapies to foster rehabilitation by stimulating targeted areas having residual function and/or plasticity and therefore able to replace the damaged areas.
Improving synergies between public research systems (UNIMI and Polyclinic), private ones (Humanitas) and manufacturers (Newronika and WISE) to create a value chain that groups their expertise to develop innovative therapies for the benefit of large population groups with motor disabilities.
These therapies address the need to have new tools to deal with the problems associated with an ageing population, including strokes, which mainly affects older people. The availability of advanced therapies in key areas of rehabilitation and treatment of nervous system diseases is strategic in an ageing society.
The current rehabilitation therapies that involve cortical stimulation to date are limited to the use of non-invasive stimulation systems that do not have the necessary precision and intensity on the motor areas concerned. A solution that includes an implantable device operates continuously without the need for frequent recourse to rehabilitation facilities. The patient does not have to "wear" bulky devices.
The manufacturing technology for the highly conformable electrodes is a key enabling factor, allowing the direct stimulation of brain areas that today are poorly accessible can allow the advent of a cutting-edge therapy.