Periodic Reporting for period 2 - ReverseParalysis (BRAIN-SPINE INTERFACES TO REVERSE UPPER- AND LOWER-LIMB PARALYSIS)
Periodo di rendicontazione: 2023-05-01 al 2025-04-30
Spinal cord injury (SCI) is a devastating condition that disrupts the communication between the brain and spinal cord, leading to severe impairments of arm, hand, and leg function. These impairments affect independence, quality of life, and social participation, while the costs of lifelong care exceed €2.5 million per person. Despite this enormous medical, societal, and economic burden, there are currently no approved therapies that restore motor function after SCI.
The ReverseParalysis project was launched to address this unmet need. Building on over a decade of pioneering research supported by European Research Council grants, the consortium had already demonstrated the feasibility of brain–spine interfaces (BSIs). These systems decode signals of movement intention from the brain and translate them into targeted electrical stimulation of the spinal cord. In animal models, BSIs restored walking and arm movements, and in a landmark case a person with chronic paralysis was able to walk again outdoors. However, these first prototypes were based on repurposed devices not designed for this purpose, limiting their performance and potential for clinical translation.
The objective of ReverseParalysis was to move from proof-of-concept to robust, fully implantable medical systems. To achieve this, the project integrated two breakthrough technologies: WIMAGINE, the only implantable neurosensor able to record brain activity wirelessly with high precision, and ARC-IM, the only neurostimulation platform designed specifically for movement recovery after paralysis. By combining these, the consortium developed two BSI systems—one for upper-limb function and one for walking—that were optimized for clinical use.
The pathway to impact was designed in three steps: integration of the technologies into implantable systems; clinical trials to assess safety, performance, and usability; and the generation of industrial specifications for next-generation devices. This pathway directly supports European priorities in health innovation and disruptive medical technologies. The expected impact is transformative: improved independence and quality of life for people with paralysis, reduced care costs for families and healthcare systems, and positioning of Europe as a global leader in neurotechnology. Social sciences and humanities contributed by ensuring that patient and clinician perspectives informed design, and by embedding ethical frameworks to guide the responsible development of invasive neurotechnologies.
The ReverseParalysis project was launched to address this unmet need. Building on over a decade of pioneering research supported by European Research Council grants, the consortium had already demonstrated the feasibility of brain–spine interfaces (BSIs). These systems decode signals of movement intention from the brain and translate them into targeted electrical stimulation of the spinal cord. In animal models, BSIs restored walking and arm movements, and in a landmark case a person with chronic paralysis was able to walk again outdoors. However, these first prototypes were based on repurposed devices not designed for this purpose, limiting their performance and potential for clinical translation.
The objective of ReverseParalysis was to move from proof-of-concept to robust, fully implantable medical systems. To achieve this, the project integrated two breakthrough technologies: WIMAGINE, the only implantable neurosensor able to record brain activity wirelessly with high precision, and ARC-IM, the only neurostimulation platform designed specifically for movement recovery after paralysis. By combining these, the consortium developed two BSI systems—one for upper-limb function and one for walking—that were optimized for clinical use.
The pathway to impact was designed in three steps: integration of the technologies into implantable systems; clinical trials to assess safety, performance, and usability; and the generation of industrial specifications for next-generation devices. This pathway directly supports European priorities in health innovation and disruptive medical technologies. The expected impact is transformative: improved independence and quality of life for people with paralysis, reduced care costs for families and healthcare systems, and positioning of Europe as a global leader in neurotechnology. Social sciences and humanities contributed by ensuring that patient and clinician perspectives informed design, and by embedding ethical frameworks to guide the responsible development of invasive neurotechnologies.
During the project, the consortium successfully developed and tested two implantable BSI systems: ARCBSI-UP for arm and hand function, and ARCBSI-LW for walking.
On the technical side, the ARCIM neurostimulation platform was enhanced with new electrode arrays tailored to spinal segments controlling movement, and new implantable pulse generators with improved reliability, longer battery life, and lower latency. The WIMAGINE system was upgraded with a new terminal transmitting 64 channels per implant, tripled energy autonomy, and reduced size. Embedded software was redesigned to operate on compact computing units, paving the way for portable applications.
Advanced brain–computer interface algorithms were created to improve calibration. These algorithms increased accuracy and responsiveness, enabling natural and intuitive control.
Two clinical studies provided the first demonstration of the technology in people with spinal cord injury. Participants with severe paralysis were able to regain meaningful control of arm, hand, and leg movements with the help of the brain–spine interface systems. Beyond enabling real-time movement, rehabilitation supported by the technology also showed signs of promoting neurological recovery, suggesting that the benefits could extend beyond device use.
By the end of the project, all planned milestones were achieved. Regulatory approvals were secured, patients were implanted successfully, and industrial-grade specifications for BSI products were delivered. Scientific impact was reinforced through a landmark publication in Nature and new peer-reviewed work on decoding methods, establishing Europe’s leadership in this field.
On the technical side, the ARCIM neurostimulation platform was enhanced with new electrode arrays tailored to spinal segments controlling movement, and new implantable pulse generators with improved reliability, longer battery life, and lower latency. The WIMAGINE system was upgraded with a new terminal transmitting 64 channels per implant, tripled energy autonomy, and reduced size. Embedded software was redesigned to operate on compact computing units, paving the way for portable applications.
Advanced brain–computer interface algorithms were created to improve calibration. These algorithms increased accuracy and responsiveness, enabling natural and intuitive control.
Two clinical studies provided the first demonstration of the technology in people with spinal cord injury. Participants with severe paralysis were able to regain meaningful control of arm, hand, and leg movements with the help of the brain–spine interface systems. Beyond enabling real-time movement, rehabilitation supported by the technology also showed signs of promoting neurological recovery, suggesting that the benefits could extend beyond device use.
By the end of the project, all planned milestones were achieved. Regulatory approvals were secured, patients were implanted successfully, and industrial-grade specifications for BSI products were delivered. Scientific impact was reinforced through a landmark publication in Nature and new peer-reviewed work on decoding methods, establishing Europe’s leadership in this field.
The project demonstrated for the first time that fully implantable BSIs can restore natural movements in people with paralysis. The results provide a solid foundation for industrialization, regulatory approval, and large-scale clinical trials. Patient outcomes confirm not only technical feasibility and safety but also the potential for long-term functional recovery, marking a step change in the treatment of SCI.
The economic impact is significant: the addressable market in Europe and the United States is estimated in the billions of euros annually, while healthcare systems could see major cost reductions through reduced care needs. The societal impact is equally strong, enabling greater independence and reintegration of people with SCI into social and professional life.
To ensure full uptake, further large-scale trials will be required, along with supportive regulatory pathways, continued access to financing, and a strong framework for intellectual property. Engagement with industry partners and standardization bodies will be key to ensuring the smooth transition from clinical prototypes to commercial medical devices.
The economic impact is significant: the addressable market in Europe and the United States is estimated in the billions of euros annually, while healthcare systems could see major cost reductions through reduced care needs. The societal impact is equally strong, enabling greater independence and reintegration of people with SCI into social and professional life.
To ensure full uptake, further large-scale trials will be required, along with supportive regulatory pathways, continued access to financing, and a strong framework for intellectual property. Engagement with industry partners and standardization bodies will be key to ensuring the smooth transition from clinical prototypes to commercial medical devices.