Project: Rehabilitation Enhanced by Neuro-ElectroStimulation of upper limb InjurieS

The goal: to improve substiantially the treatment of complex upper limb injuries by integrating functional electrostimulation (FES) in the treatment._x000D__x000D_Acute and complex injuries after work accidents or household accidents are numerous. The biggest proportion of them are hand injuries or upper limb injuries._x000D_Complex injuries of the upper extremities, and particularly hand structures, bring a therapeutic challenge when nerve and muscles are affected at the same time. Despite acute surgery for reconstruction that must be performed (e.g. re-suturing and/or grafting of nerve defects), the neuromuscular endplates of the muscle frequently degenerate resulting in muscle hypotrophy. In addition, muscles lose their functionality over time and cannot respond adequately. This is based on the fact that neural re-growth after surgical bridging/grafting is a long-term process of approximately 12–18 months._x000D__x000D_The amount of complex upper limb/hand injuries has continuously increased over the last decade in Europe. For Germany only, 1000 injuries of the upper extremities which are suitable for such type of treatment occur annually. Of these injuries, 70% are due to chain and rotating saw accidents. _x000D_When upper limb injuries concern the section of a nerve or even an amputation of a part of the upper limb, both surgery for the nerve reconstruction and rehabilitation have a high cost (about 150 k€ direct medical/rehab costs per patient). Moreover, the direct medical treatment, the subsequent rehabilitation phase and the requirements for training back to the job or re-training can last 1-3 years. It is therefore the major medical aim of the project to shorten this period of time, improve functional outcome and reduce substantially costs (by at least one third). _x000D__x000D_The idea: to get benefit from electrical stimulation effect on neural re-growth and on muscle function preservation._x000D__x000D_In several experimental setups (incl. animal experiments, acute clinical trials), the beneficial effect of electrical stimulation on neural re-growth and on muscle function preservation has been shown (e.g. Vivo et al. 2008, Casals-Diaz et al. 2009). Indeed, studies have shown electrical stimulation applied after nerve injury promotes axonal regeneration that influences the degree of functional recovery._x000D_Electrical stimulation could help to:_x000D_- speed-up and improve growth of damaged nerves; _x000D_- provide an afferent signal to the brain for central control of this nerve reconstruction process; _x000D_- directly keep the –otherwise degenerating– motor endplate alive so that the muscle does not suffer from atrophy._x000D__x000D_The means: to stimulate electrically the proximal and the distal ends of the nerve section during the whole rehabilitation procedure._x000D__x000D_Electrical stimulation is a well-known therapy which has been identified for many years. It consists in sending electrical pulses to the nerves or muscles by means of electrodes or electrode arrays, implanted or not, in order to treat several pathologies._x000D_The aim of the present proposal is to design a clinically applicable device for stimulation of the upper limb and/or hand. It consists in developing two major components, respectively stimulating electrodes including a dedicated pulse generator and its controller. While the controller will reCO external, the pulse generator could possibly be implantable if it turns out to be useful and efficient._x000D_At the same time, a miniaturized recording setup and its dedicated software for the data analysis will be developed._x000D_In acute clinical trials with such complex injuries, the device will be tested in parallel to conventional surgical strategies._x000D__x000D_The team:_x000D__x000D_The CO participant is NEUROMEDICS, subsidiary of the MXM group. This R&D performing SME is focused on the development of Active Implantable Medical Devices (AIMD). By dint of the experience in cochlear implants (NEURELEC subsidiary) or in FES in SUAW project (Stand-Up And Walk), NEUROMEDICS has all the expertise and facilities to design and build a FES device aimed to stimulate nerve after nerve injuries._x000D__x000D_UKB hospital is a major german clinic and the clinical research P of the project. UKB is specialized in FES research conducted by the Dept Clin Tech Res and has another clinical and surgical speciality in the treatment/surgical reconstruction/rehabilitation of complex upper limb injuries. A total of 2000 upper limb procedures with at least 200 severe injuries are surgically treated per year. This includes nerve grafting, and transplantation of fascia and muscles._x000D__x000D_INOMED is a medical technology company developing nerve protection instruments and systems for precisely targeted patient treatment. Working with physicians and scientists, inomed develops new tools and methods in the fields of intraoperative neuromonitoring (IOM), functional neurosurgery, pain therapy and neurological diagnostics. It is market leader in Germany for neuromonitoring during thyroid surgery. It has thus the experience to provide IOM devices.

Acronym	RENESIS (Reference Number: 5452)
Duration	01/04/2011 - 01/10/2014
Project Topic	The goal: to enhance substantially the treatment of complex upper limb injuries._x000D_ The idea: to get benefit from electrical stimulation effect on neural re-growth and on muscle function preservation. _x000D_ The means: to stimulate both ends of the nerve defect during the whole rehabilitation procedure.
Project Results (after finalisation)	An implantable cuff electrode for upper limb is designed and produced ; scalable design will able to adress different sizes of nerves._x000D_A per-operative stimulation system has been developped and validated with associated software._x000D_A practical method and therapeutic protocol has been identified._x000D_The method has also been confirmed safe and secure
Network	Eurostars
Call	Eurostars Cut-Off 4

Project partner

Number	Name	Role	Country
3	inomed Medizintechnik GmbH	Partner	Germany
3	OBELIA	Coordinator	France
3	Unfallkrankenhaus Berlin - Dept. Clin Tech Research and Dept. Hand-Micro & Replant Surgery	Partner	Germany