Summary
Very advanced stimulation paradigms applied to peripheral nervous system (PNS) have been studied for years even decades among
which the 3D current distribution through multi-contact epineural electrodes. Non rectangular stimulus waveforms are also of strong
interest to provide more efficient or fibre type selective stimulation. However none were implemented in an Active Implanted Medical
Device and thus almost none validated through clinical trials. One of the reasons is the high complexity of the needed analogue front
end and its safe control by a microcontroller or a digital system. AI-HAND project aims at developing a breakthrough, ASIC based
technology, together with a specific self adapting epineural multi contact electrode to provide such an AIMD. The demonstration of
the clinical relevance of such an approach will be achieved through a first-in-man proof of concept aiming at the restoration of hand
movements in persons with complete quadriplegia. It means that a full innovative device should be developed and validated in
animals, but the real added value will be supported by the clinical trial; indeed, no animal model exists while the clinical needs is
clearly stated by clinicians and patients. Thus this project will innovate concerning both the technology and the therapeutic approach
with a minimally invasive concept. Indeed, spatial selectivity allows to stimulate nerves selectively targeting muscles through 3D
currents shaping instead of implanting one electrode per muscle. The technology clearly addresses generic issues so that the paradigms and the innovative technology can be further used to stimulate the central nervous system (spinal cord and brain) and, on a long term basis, may drastically open new therapeutics for medical needs that are still unmet.
which the 3D current distribution through multi-contact epineural electrodes. Non rectangular stimulus waveforms are also of strong
interest to provide more efficient or fibre type selective stimulation. However none were implemented in an Active Implanted Medical
Device and thus almost none validated through clinical trials. One of the reasons is the high complexity of the needed analogue front
end and its safe control by a microcontroller or a digital system. AI-HAND project aims at developing a breakthrough, ASIC based
technology, together with a specific self adapting epineural multi contact electrode to provide such an AIMD. The demonstration of
the clinical relevance of such an approach will be achieved through a first-in-man proof of concept aiming at the restoration of hand
movements in persons with complete quadriplegia. It means that a full innovative device should be developed and validated in
animals, but the real added value will be supported by the clinical trial; indeed, no animal model exists while the clinical needs is
clearly stated by clinicians and patients. Thus this project will innovate concerning both the technology and the therapeutic approach
with a minimally invasive concept. Indeed, spatial selectivity allows to stimulate nerves selectively targeting muscles through 3D
currents shaping instead of implanting one electrode per muscle. The technology clearly addresses generic issues so that the paradigms and the innovative technology can be further used to stimulate the central nervous system (spinal cord and brain) and, on a long term basis, may drastically open new therapeutics for medical needs that are still unmet.
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More information & hyperlinks
Web resources: | https://cordis.europa.eu/project/id/101099916 |
Start date: | 01-08-2023 |
End date: | 31-01-2027 |
Total budget - Public funding: | 2 999 834,25 Euro - 2 999 834,00 Euro |
Cordis data
Original description
Very advanced stimulation paradigms applied to peripheral nervous system (PNS) have been studied for years even decades amongwhich the 3D current distribution through multi-contact epineural electrodes. Non rectangular stimulus waveforms are also of strong
interest to provide more efficient or fibre type selective stimulation. However none were implemented in an Active Implanted Medical
Device and thus almost none validated through clinical trials. One of the reasons is the high complexity of the needed analogue front
end and its safe control by a microcontroller or a digital system. AI-HAND project aims at developing a breakthrough, ASIC based
technology, together with a specific self adapting epineural multi contact electrode to provide such an AIMD. The demonstration of
the clinical relevance of such an approach will be achieved through a first-in-man proof of concept aiming at the restoration of hand
movements in persons with complete quadriplegia. It means that a full innovative device should be developed and validated in
animals, but the real added value will be supported by the clinical trial; indeed, no animal model exists while the clinical needs is
clearly stated by clinicians and patients. Thus this project will innovate concerning both the technology and the therapeutic approach
with a minimally invasive concept. Indeed, spatial selectivity allows to stimulate nerves selectively targeting muscles through 3D
currents shaping instead of implanting one electrode per muscle. The technology clearly addresses generic issues so that the paradigms and the innovative technology can be further used to stimulate the central nervous system (spinal cord and brain) and, on a long term basis, may drastically open new therapeutics for medical needs that are still unmet.
Status
SIGNEDCall topic
HORIZON-EIC-2022-PATHFINDEROPEN-01-01Update Date
12-03-2024
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