Periodic Reporting for period 2 - BIC ONE (Brain Interchange ONE SR—the implantable neuromodulation technology for stroke rehabilitation)
Okres sprawozdawczy: 2023-11-01 do 2024-10-31
Worldwide,13 million people experience a stroke every year. In stroke, a certain brain area is damaged, leading to a loss or impairment of a particular body function. The mortality of stroke is 50%. Stroke survivors show symptoms of paralysis, speech or mental disordes, varying strongly in intensity across individuals.
The rehabilitation treatment takes several months and has the aim to regain lost functionality. In case of paralysis, this treatment consists of conventional physio or occupational therapy. The therapeutic success relies on the brains ability to reorganize itself (neuroplasticity) when the corresponding motor tasks are executed by the patient. Some patients recover quickly, some show almost no response to the therapy and remain heavily impaired for the rest of their lives.
Neuroscience has discovered that electrical stimulation of the brain can improve neuroplasticity resulting in improved learning capability. In combination with conventional therapy, this can improve therapeutic results and lead to a more independent life.
CorTec has developed the “Brain Interchange” (BIC) system that provides an elaborated electrical stimulation to enhance neuroplasticity. This system consist of an implanted electronic device that communicates with the brain using electricity. The implanted device wirelessly communicates with a laptop computer (PC) that receives brain signals sensed by the implant. An algorithm on the PC analysis these signals and takes decisions on electrical brain stimulation which is then executed by the implanted electronics.
The EIC grant permits CorTec to finalize development of the BIC system, permitting a subsequent start of a pivotal trial, allowing commercialization.
The rehabilitation treatment takes several months and has the aim to regain lost functionality. In case of paralysis, this treatment consists of conventional physio or occupational therapy. The therapeutic success relies on the brains ability to reorganize itself (neuroplasticity) when the corresponding motor tasks are executed by the patient. Some patients recover quickly, some show almost no response to the therapy and remain heavily impaired for the rest of their lives.
Neuroscience has discovered that electrical stimulation of the brain can improve neuroplasticity resulting in improved learning capability. In combination with conventional therapy, this can improve therapeutic results and lead to a more independent life.
CorTec has developed the “Brain Interchange” (BIC) system that provides an elaborated electrical stimulation to enhance neuroplasticity. This system consist of an implanted electronic device that communicates with the brain using electricity. The implanted device wirelessly communicates with a laptop computer (PC) that receives brain signals sensed by the implant. An algorithm on the PC analysis these signals and takes decisions on electrical brain stimulation which is then executed by the implanted electronics.
The EIC grant permits CorTec to finalize development of the BIC system, permitting a subsequent start of a pivotal trial, allowing commercialization.
We worked on the development of implantable connectors, minimal invasive electrodes, impact resistant implant package, wireless link improvements and reduction of heat dissipated by the implant, data cloud and MRI compatibility.
A disconnection between electrodes and implant electronics using implantable connectors is desired, since it has several advantages related to implantation surgery. CorTec developed and built 8-way implantable connectors: The female connector part is attached to the implant electronics while the male part is located at the end of the electrode cable. After prototyping, CorTec has carried out extensive tests on long-term electrical performance, mechanical robustness and biocompatibility. The electrodes themselves were developed to be slightly stiffer, permitting burr-hole implantation, avoiding the need for a very invasive craniotomy.
The implant electronic itself uses wireless links for communication and power supply. The wireless communication link operates in the ISM band at 2.4 - 2.5GHz and is prone to interfere with other mobile devices. Therefore, a data collision minimization strategy was developed and implemented. The system selects one of 7 available channels inside the band for its communication and once this channel is disturbed by another wireless devices, the system switches to another channel. This method led to a dramatic improvement of wireless link stability. Further reliability of wireless communication was achieved by re-locating the antenna from the communication unit to the headpiece, effectively reducing the potential constellations of distance and angles between implanted and body-external communication antennas.
The implant consumes electric power, which is eventually dissipated as heat. Heat can lead to biological tissue damage, and therefore has to be minimized. Temperatures were found to be just below acceptable limits, but only with little safety margin. Modifying the electronic circuitry reduced power consumption by 30%, resulting in lower implant temperatures. Furthermore, the hermetic package that protects implanted electronics from body liquids was strengthened to meet latest normative requirements on mechanical impact robustness. We exchanged the Al2O3 packaging lid by a ZrO2 lid.
The compatibility of the system with a 3.0T MRI scanner was investigated with the result, that heating is most likeley not to reach critical levels of 2.0K neither do the magnetic forces, but the implanted system causes by it's permanent magnet a strong image shadowing of about 50mm radius, compromising the diagnostic purpose of MRI head scans.
The system streams the recorded brain data and also the protocol of system events to the newly developed and build cloud, where (still) simple visualisation tools permit the display of the data.
Cybersecurity plays an important role - perhaps not so much in the first clinical feasibility study - but in the later product. Therefore cybersecurity measures such as AES128 decryption of the wireless communication was implemented. A third party evaluated the effectiveness of our cycbersecurity measures with some recommendation for improvement for the final product.
A disconnection between electrodes and implant electronics using implantable connectors is desired, since it has several advantages related to implantation surgery. CorTec developed and built 8-way implantable connectors: The female connector part is attached to the implant electronics while the male part is located at the end of the electrode cable. After prototyping, CorTec has carried out extensive tests on long-term electrical performance, mechanical robustness and biocompatibility. The electrodes themselves were developed to be slightly stiffer, permitting burr-hole implantation, avoiding the need for a very invasive craniotomy.
The implant electronic itself uses wireless links for communication and power supply. The wireless communication link operates in the ISM band at 2.4 - 2.5GHz and is prone to interfere with other mobile devices. Therefore, a data collision minimization strategy was developed and implemented. The system selects one of 7 available channels inside the band for its communication and once this channel is disturbed by another wireless devices, the system switches to another channel. This method led to a dramatic improvement of wireless link stability. Further reliability of wireless communication was achieved by re-locating the antenna from the communication unit to the headpiece, effectively reducing the potential constellations of distance and angles between implanted and body-external communication antennas.
The implant consumes electric power, which is eventually dissipated as heat. Heat can lead to biological tissue damage, and therefore has to be minimized. Temperatures were found to be just below acceptable limits, but only with little safety margin. Modifying the electronic circuitry reduced power consumption by 30%, resulting in lower implant temperatures. Furthermore, the hermetic package that protects implanted electronics from body liquids was strengthened to meet latest normative requirements on mechanical impact robustness. We exchanged the Al2O3 packaging lid by a ZrO2 lid.
The compatibility of the system with a 3.0T MRI scanner was investigated with the result, that heating is most likeley not to reach critical levels of 2.0K neither do the magnetic forces, but the implanted system causes by it's permanent magnet a strong image shadowing of about 50mm radius, compromising the diagnostic purpose of MRI head scans.
The system streams the recorded brain data and also the protocol of system events to the newly developed and build cloud, where (still) simple visualisation tools permit the display of the data.
Cybersecurity plays an important role - perhaps not so much in the first clinical feasibility study - but in the later product. Therefore cybersecurity measures such as AES128 decryption of the wireless communication was implemented. A third party evaluated the effectiveness of our cycbersecurity measures with some recommendation for improvement for the final product.
The technology is one important aspect of the concept to improve stroke rehabilitation. Another one is the clinical effectiveness.
No other high-bandwidth closed-loop stimulator implants exist that provide very fast closed-loop and also some MRI compatibility.
The first use on 2 epilepsy patients showed that the general concept, the technology and the software is capable of beta-phase locked brain stimulation for increasing neuroplasticity (our stroke treatment) without being compromised by the systems own stim. artifacts
No other high-bandwidth closed-loop stimulator implants exist that provide very fast closed-loop and also some MRI compatibility.
The first use on 2 epilepsy patients showed that the general concept, the technology and the software is capable of beta-phase locked brain stimulation for increasing neuroplasticity (our stroke treatment) without being compromised by the systems own stim. artifacts