STIMULAIS

A novel muscular micro-electro-stimulation device for the enhanced treatment of adolescent idiopathic scoliosis avoiding bracing and invasive open surgery

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 Obiettivo del progetto (Objective)

'Adolescent idiopathic scoliosis (AIS) is a progressive structural spinal deformity that affects around 2-3% of children aged between 10 and 16 in the world. Current conservative treatments (bracing and physiotherapy) are not sufficiently effective in stopping curve progression, so that more than 40.000 patients per year need an invasive fusion surgery that eliminates spine mobility. Recent studies evidenced that the spine deformity is a musculoskeletal expression of a central nervous system disorder that affects the paraspinal muscles inducing an imbalance of forces acting over the vertebral segments. The results of these studies and the work of a renowned clinical research group participating in the project (UCV) constitute the basis for the StimulAIS project, whose main objective is the development of a novel device for the treatment of AIS by muscular electro-stimulation of the deep paraspinal rotator muscles. The novel system will provide a customized treatment protocol to each patient, with targeted stimulation and real time control to maintain stimulation effectiveness and maximize treatment outcome. This device will be capable of stopping progression of the curvature and of correcting it, avoiding the side effects of current solutions, reducing the rate of surgery, and being cost effective compared to the abovementioned methods. The consortium integrates three SMEs along the product value chain, experienced in manufacturing and distribution of medical devices, surgical instruments and electrotherapy systems. The core R&D activities will be carried out by UCV, and two more RTD centers, namely IBV and FRAUNHOFER-IPMS, who have the necessary capabilities to achieve the objectives through development, integration and validation stages. The expected potential market for the StimulAIS device is about 400M€ in Europe and total Consortium’s turnover expected within four years after implementation will reach over 45M€, being around 9M€ the consortium benefits.'

Descrizione progetto (Article)

The http://www.stimulais.com (STIMULAIS) project is focused on developing an alternative treatment for adolescent idiopathic scoliosis (AIS) through the muscular electro-stimulation of the paraspinal deep rotator muscles. This device will mean tremendous improvement in AIS treatment. Not only will it stop the progression of the curvature, but it will also correct it.

Furthermore, the stimulation protocol will implement an innovation in the technology using sensor electromyography (EMG) and motor function through a feedback loop control. This will allow the device to be adapted realtime and maintain stimulation effectiveness, meaning customised treatment for the patient. Another device breakthrough is small size and the minimally invasive procedure required to implant it.

The project has created a consortium of members with varied and critical expertise for successful collaboration throughout its research and development activities. The scientists are tackling the objectives in three stages: scientific knowledge generation, development of components and prototype, and integration and validation of the final technology.

Research was carried out to ensure the optimal combination of technical parameters in order to achieve a successful electro-stimulation treatment. This meant activities such as analysing EMG data about bioelectric muscular activity, in order to characterise relationships between EMG data and electro-stimulation that will be used as inputs of the stimulation protocol of the spine.

Various consortium members also worked on different parts of the device development. The hardware components, the stimulation protocol algorithm, the defining of the actual procedure and several other aspects were carried out by various members. The remaining tasks involve obtaining functional prototypes, the external control console and the necessary minimally invasive surgical instruments.

This project will provide the small and medium-sized businesses of the consortium with greater capabilities, increased value and competitiveness, and improved technological skills. The project and the device will also benefit Europe as a whole, reducing surgeries and increasing savings. This treatment, able to not only stop curvature progression but correct it as well, will have many positive economic and social consequences The most important will be the improvement of the lives of the many children battling AIS.