Periodic Reporting for period 1 - AI-HAND (Advanced Intelligent stimulation device: HAND movement restoration)
Periodo di rendicontazione: 2023-08-01 al 2024-07-31
The AI-HAND project aims to develop a pioneering active medical implanted device (AIMD) to restore grasping movements in individuals with tetraplegia (complete arm paralysis). This device will deliver electrical impulses via epineural electrodes implanted around the median and radial nerves. To date, many individuals with complete tetraplegia have no means of regaining hand movements, as they are often ineligible for functional surgery. These individuals will be the first to benefit from the AI-HAND's new approach. The project introduces groundbreaking innovations such as multiphasic stimulus waveforms, multiple synchronized current sources for 3D current shaping over a multi-contact neural cuff electrode, and complex interleaved stimulation instead of standard rectangular single-source sequenced stimulation. These advancements address previously unmet needs. AI-HAND aims to implement cutting-edge electrophysiological findings through radically innovative, fully safe, and software-free implant technologies, paving the way for a powerful new generation of generic active medical implanted devices (AIMDs).
The project's success will be evaluated based on two primary high-risk, high-reward objectives:
1. Delivering a pre-series of AIMDs, including control and configuration software. Achieving this goal requires successfully navigating all stages from basic theoretical concepts through to the design and development of both hardware and software. The key performance indicator (KPI) for this objective is the "Number of prototypes developed and used in a preclinical/clinical environment", alongside a significant progression from Technology Readiness Level (TRL) 3 (major components like Application-Specific Integrated Circuit (ASICs) and final electrodes are not yet fabricated) or TRL4 (main concepts have been proven) to TRL7, indicating that the full AIMD is in its final form and tested;
2. Conducting a successful First-In-Man (FIM) clinical trial with preliminary proof of clinical benefits. Regardless of how innovative the technology is, it is only valuable if it demonstrates clear clinical benefits. The FIM objectives should demonstrate that the device is 1) safe, 2) easy to implant, 3) effective in providing evidence for the research hypothesis regarding selective electrical stimulation, and 4) beneficial to the patient.
The project's success will be evaluated based on two primary high-risk, high-reward objectives:
1. Delivering a pre-series of AIMDs, including control and configuration software. Achieving this goal requires successfully navigating all stages from basic theoretical concepts through to the design and development of both hardware and software. The key performance indicator (KPI) for this objective is the "Number of prototypes developed and used in a preclinical/clinical environment", alongside a significant progression from Technology Readiness Level (TRL) 3 (major components like Application-Specific Integrated Circuit (ASICs) and final electrodes are not yet fabricated) or TRL4 (main concepts have been proven) to TRL7, indicating that the full AIMD is in its final form and tested;
2. Conducting a successful First-In-Man (FIM) clinical trial with preliminary proof of clinical benefits. Regardless of how innovative the technology is, it is only valuable if it demonstrates clear clinical benefits. The FIM objectives should demonstrate that the device is 1) safe, 2) easy to implant, 3) effective in providing evidence for the research hypothesis regarding selective electrical stimulation, and 4) beneficial to the patient.
During the first year of the project, the AI-HAND Consortium has submitted nine deliverables and achieved two milestones. All deliverables due by Month 12 were submitted on time, with a few justified exceptions.
The project team has made considerable progress towards achieving its main scientific objectives. responded promptly to both anticipated and unforeseen risks to ensure steady work progress and maintain effective cooperation among partners.
The project team has made considerable progress towards achieving its main scientific objectives. responded promptly to both anticipated and unforeseen risks to ensure steady work progress and maintain effective cooperation among partners.
At the current stage of the project, it is premature to discuss definitive results.
However, during the first year of the project, the specifications of the main components of the medical device were completed. They include the electrode’s specifications (D2.1) the ASIC specifications (D3.1) and the IPG specifications (D4.1).
Three preliminary outcomes with significant scientific potential can also be highlighted: the completion of the clinical trial protocol for CT1 (WP6), the initial results from the first animal experiments conducted in WP5, which are currently undergoing thorough analysis, and the licence submission of the research electrode model (WP2). Detailed strategies for the exploitation and protection of forthcoming project results are outlined in project deliverable D1.5 "Exploitation & IPR Strategy Plan".
However, during the first year of the project, the specifications of the main components of the medical device were completed. They include the electrode’s specifications (D2.1) the ASIC specifications (D3.1) and the IPG specifications (D4.1).
Three preliminary outcomes with significant scientific potential can also be highlighted: the completion of the clinical trial protocol for CT1 (WP6), the initial results from the first animal experiments conducted in WP5, which are currently undergoing thorough analysis, and the licence submission of the research electrode model (WP2). Detailed strategies for the exploitation and protection of forthcoming project results are outlined in project deliverable D1.5 "Exploitation & IPR Strategy Plan".