Periodic Reporting for period 1 - ReverseParalysis (BRAIN-SPINE INTERFACES TO REVERSE UPPER- AND LOWER-LIMB PARALYSIS)
Okres sprawozdawczy: 2022-05-01 do 2023-04-30
A spinal cord injury (SCI) alters the communication between the brain and spinal cord. The consequences are dramatic impairments of upper-limb and lower-limb motor functions, which have a profound impact on the affected person, their family, and society. Currently, there are no approved therapies for SCI. The resulting costs of care amount to more than 2.5 M over the lifetime of a person with SCI. Two ERCs combined with two ERC-PoCs enabled us to prototype two brain-spine interfaces (BSIs) that link the intended movements decoded from motor cortex activity to precise electrical stimulations of the spinal cord to promote these movements. These BSIs restored walking and arm/hand movements in nonhuman primate models of SCI, and as we report here, enabled one patient with chronic paralysis to walk again outdoors. These prototypes were partly based on repurposed devices that were not optimized for the intended applications, and thus presented shortcomings. Here, we propose to integrate two breakthrough technologies to develop two fully-implantable BSIs that will remedy these limitations. The first technology consists of the only existing fully-implantable neurosensor for wireless monitoring of cortical activity in humans based on high-density grids positioned over the dura mater. The second technology is the only implantable neurostimulation system dedicated to the recovery of movement after paralysis. This system combines an implantable pulse generator that enables highly reliable, real-time control of spinal cord stimulation, and a portfolio of electrode arrays that have been designed to leverage the mechanisms through which this stimulation restores movement. Two small scale clinical trials will demonstrate that these BSIs restore lower-limb and upper-limb movements in humans with chronic paralysis. These studies will provide specifications for industrial versions of the BSIs, opening the path to a commercially-viable revolution for people living with paralysis.
Reverse-Paralysis project started in May 2022 by an official Kick-off gathering all partners in a face-to-face meeting in Lausanne, Switzerland. A synopsis of the project can be found at www.reverse-paralysis.com. The project was presented at Leti Innovation Days 2022 and announced on CEA’s website. Our BSI concept was nominated for and won the first place of the BCI AWARD 2022. It was presented by EPFL during the online award ceremony.
During an initial brainstorming session, the consortium explored various system architectures for lumbar and cervical use cases in hospital and in daily use environments. 3 design concepts emerged from this comprehensive analysis for ARCBSI devices aligned with a global eco-system (global concept).
User questionnaires were established by the consortium and a first set of interviews of patients were conducted by clinicians in the Netherlands and in Switzerland. User needs were elaborated and refined with the outcome of the interviews.
ARCIM and WIMAGINE systems were successfully delivered to EPFL for integration.
In preparation of the clinical validation, a submission for upper-limb SCI (UP-2 study) was filed 2 months ahead of schedule.
The project is on track.
During an initial brainstorming session, the consortium explored various system architectures for lumbar and cervical use cases in hospital and in daily use environments. 3 design concepts emerged from this comprehensive analysis for ARCBSI devices aligned with a global eco-system (global concept).
User questionnaires were established by the consortium and a first set of interviews of patients were conducted by clinicians in the Netherlands and in Switzerland. User needs were elaborated and refined with the outcome of the interviews.
ARCIM and WIMAGINE systems were successfully delivered to EPFL for integration.
In preparation of the clinical validation, a submission for upper-limb SCI (UP-2 study) was filed 2 months ahead of schedule.
The project is on track.
The ARCBSI system is the only product in the world with proven potential for reversing paralysis. It is a world premiere to have developed a wireless system for chronic implantation which can turn the patient thoughts into actions.