Agilis Project: Getting back on track

Date :
Changed on 15/06/2020
The Agilis project aims to develop a solution to restore grip functions in people with complete paralysis of the upper limbs (tetraplegia) but with preserved voluntary control of the shoulder and elbow.

The ultimate goal is to enable them to regain autonomy and improve their quality of life.
Projet Agilis - David Guiraud - Christine Azevedo Coste - Inria Sophia Antipolis Méditerranée
Inria / Photo G. Scagnelli

The AGILIS project, in concrete terms

Our approach is based on the electrical stimulation of two nerves of the upper limb via multi-contact cuff electrodes implanted above the participants' elbows. We have developed an electrical stimulator to precisely control the current injected into each electrode contact. The objective of the work in this first phase of the project was to validate the feasibility of selectively activating subsets of muscles innervated by the median and radial nerves from a unique electrode on each nerve. 8 volunteers agreed to have us intervene during a scheduled surgery to evaluate the selectivity of different stimulation configurations. An electrode was positioned on one of the two nerves and the induced responses observed and evaluated.

The other side of the project concerns the user's control interface of the neuroprosthesis, as the user should be able to control the stimulation triggering according to his/her willingness to open his/her hand, grasp an object of a given shape...

Christine Azevedo, David Guiraud, Charles Fattal and Jacques Teissier explain the ins and outs of the current research project (Film made in 2018).
 

Implementating via implanting

The second phase of the Agilis project has started with the support of EIT Health.

The objective is to implant two electrodes for 30 days in the arms of two volunteers with complete tetraplegia and to follow longitudinally the technical and functional performances in order to evaluate the interest of our approach. Only the electrodes will be implanted.

The surgical interventions should have taken place in April 2020 but were postponed to the autumn due to COVID-19 pandemia.

Sustainability in interactions

The project represents a long-term undertaking that requires stable human resources.
 
This is why we are continuing the work with Doctors Teissier and Fattal as well as the company Neurinnov.
 
Other partners are also involved, notably the APHP in Paris and the Bouffard Vercelli rehabilitation centre in Perpignan..

Closely linked research team and startup

Neurinnov s the result of the Camin research project-team and aims to market the AGILIS solution by developing an implant that will allow a fully implanted neuroprosthesis (electrodes and stimulator).

It is a high-tech industrial project and complex from a regulatory point of view. It could no longer remain internal to the CAMIN team.

 

The Agilis project continues to progress

The clinical trials planned in October 2020 with two volunteers will be a first validation of the complete device (stimulation and control), both technically and in terms of functional usability for the user.

The next step will be a broader validation of the approach with other volunteers and also considering the possibility of stimulating the third nerve of the arm, the ulnar nerve.

Neurinnov is currently developing an implant that will allow us to have an all-implanted solution that we will test over several months in volunteers in 3 years, we hope.

Pre-clinical trials will also be mandatory in accordance with current regulations.