Periodic Reporting for period 1 - INTRECOM (Intracranial Neuro Telemetry to Restore Communication)
Reporting period: 2022-12-01 to 2023-11-30
Not being able to communicate while still being conscious is a horrifying prospective for many patients worldwide. Patients with motor neuron disorders, trauma or stroke, risk losing complete muscle control leading to Locked-In Syndrome (LIS) which leaves them completely paralyzed and unable to communicate. This is a fearful situation with significant impact on quality of life and very high burden of care for patients, family, and care givers. Intracranial Neuro Telemetry to REstore COMmunication (INTRECOM) will provide a breakthrough for these patients by developing a novel, fully implantable Brain-Computer Interface (BCI) technology that allows for real-time brain-based computer control and communication in the home environment. This BCI system will significantly transcend current technology by providing a high-performance sustainable device, combining state-of-the-art hardware and software solutions based on Microelectronics Engineering and Artificial Intelligence (AI) to liberate LIS patients from their isolation.
INTRECOM’s ambition is to substantially advance BCI technology and validate its working principle in LIS patients in the home environment. The specific objectives of INTRECOM are to:
1. Develop a safe and fully functional high-performance BCI prototype device with 128 electrodes embedded in silicone sheets under the skull and dura for electrocorticography (ECoG grids), and innovative implantable connectors that allows safe and high-quality 24/7 brain signal recording.
2. Develop decoding algorithms based on AI that can translate brain signals to real-time computer control, as well as real-time computer speech (written or audio), with less than 1 second delay.
3. Implant the developed prototype device in 2 people with LIS and validate its working principle, including use in the home environment with initial basic functionality within weeks after implantation, and real-time intelligible speech decoding, thereby restoring communication by the end of the project.
4. Gather an unprecedented wealth of brain data through the in vivo research. Data will improve INTRECOM's hard- and software, neural signal decoding algorithms, and functionality and use of the device. Openly shared, they will advance scientific knowledge of human brain function, BCI, and therapeutic opportunities, and provide novel real-time decoding principles also for future closed-loop neurostimulation applications.
5. Show acceptability of the BCI technology by patients, caregivers, and health care professionals by the end of the project.
INTRECOM’s ambition is to substantially advance BCI technology and validate its working principle in LIS patients in the home environment. The specific objectives of INTRECOM are to:
1. Develop a safe and fully functional high-performance BCI prototype device with 128 electrodes embedded in silicone sheets under the skull and dura for electrocorticography (ECoG grids), and innovative implantable connectors that allows safe and high-quality 24/7 brain signal recording.
2. Develop decoding algorithms based on AI that can translate brain signals to real-time computer control, as well as real-time computer speech (written or audio), with less than 1 second delay.
3. Implant the developed prototype device in 2 people with LIS and validate its working principle, including use in the home environment with initial basic functionality within weeks after implantation, and real-time intelligible speech decoding, thereby restoring communication by the end of the project.
4. Gather an unprecedented wealth of brain data through the in vivo research. Data will improve INTRECOM's hard- and software, neural signal decoding algorithms, and functionality and use of the device. Openly shared, they will advance scientific knowledge of human brain function, BCI, and therapeutic opportunities, and provide novel real-time decoding principles also for future closed-loop neurostimulation applications.
5. Show acceptability of the BCI technology by patients, caregivers, and health care professionals by the end of the project.
Over the first 12 months of the project, our research and development efforts have made substantial progress in various domains related to the development of a novel brain-computer interface. We defined the high density ECoG grid layout, stiffness, and production methods, and decided about the optimal location of reference electrodes, based on offline analyses of existing ECoG data. Leveraging existing ECoG data, we developed and tested speech and hand movement decoding algorithms. User-centric approaches were used for the designs of the BCI software platform NeuroKey, the BCI Applications, and for the Data Sharing Platform. NeuroKey saw the integration of clinical data acquisition and the launch of a neural feature extraction pipeline, ensuring compatibility with high-channel-count ECoG devices. The BCI Applications aim to enhance usability of communication software for the participants. This is accomplished by enabling mouse and keyboard control and the creation of a versatile interface for click, cursor, and speech based BCI. Our Data Sharing Platform had a successful beta version launch, establishing a robust data infrastructure and seamless automatic data uploads for efficient sharing. We are working towards finalizing the designs for the ABILITY implant and associated external components, and we have successfully manufactured prototypes for testing and verification. Our research protocol has well-defined objectives, clinical study design, and outcome parameters.
For INTRECOM we will develop breakthrough BCI hardware with high-density 128-channel ECoG electrode grids along with a miniaturized wireless electronics unit with amplifier (0.4 cm thick) and implantable connectors that allow for electronics unit replacement while keeping electrodes in place. This hardware is intended to remain operational 24/7 for >10 years and is inductively charged. With this device, we will gather an enormous amount of data compared to the state-of-the-art implantable BCIs (by a factor of 100 or more). We create a high-performance and sustainable device that meets urgent needs that cannot be met otherwise for LIS patients enabling independent communication with caregivers, loved ones and society at large.
The improved BCI hardware will allow for better and cleaner data. Cleaner data, coupled with our custom machine learning decoding software, will enable direct translation of brain signals from the sensorimotor cortex to computer control signals and written or spoken speech. This will allow for a maximal delay of 1 second, for the first time making real-time conversation at home possible.
Success of this project will pave the way for making communication BCI commercially available to many thousands of severely impaired individuals, for use in everyday life, given compliance with regulatory requirements, opportunities for licensing or spin-out and validation of clinical benefit.
The improved BCI hardware will allow for better and cleaner data. Cleaner data, coupled with our custom machine learning decoding software, will enable direct translation of brain signals from the sensorimotor cortex to computer control signals and written or spoken speech. This will allow for a maximal delay of 1 second, for the first time making real-time conversation at home possible.
Success of this project will pave the way for making communication BCI commercially available to many thousands of severely impaired individuals, for use in everyday life, given compliance with regulatory requirements, opportunities for licensing or spin-out and validation of clinical benefit.