Wyss Center Receives CE Mark for NeuroKey Brain-Computer Interface

“We believe that user-friendly medical-grade neural processing software will help drive adoption of BCI technologies by clinicians and we hope that NeuroKey will bring home-use of BCIs closer to reality to improve the lives people who could benefit from BCIs for movement and communication."

George Kouvas, MBA, CTO, Wyss Center

The Wyss Center for Bio and Neuroengineering has been granted the European CE mark Class I for its NeuroKey Brain-Computer Interface device. CE marking indicates that a product has been assessed and deemed to meet European Union safety, health, and environmental protection requirements. NeuroKey makes it possible for people who are completely paralyzed and unable to speak to communicate using their own brain signals. This is the first clinical application of the NeuroKey to be launched in the EU and lays the foundation for brain-to-computer speech and other assistive tools including emergency alarms for people who cannot ask for help in another way.?

The?Wyss Center?is a non-profit?neurotechnology?research foundation in Geneva Switzerland with a mission to advance understanding of the brain to realize therapies and improve lives. Scientists at the Wyss Center are developing clinical solutions from neuroscience research and unifying neuroscience at all scales from genes to the whole brain. By pursuing innovations and new approaches in neurobiology, neuroimaging and neurotechnology, they are revealing unique insights into the mechanisms underlying the dynamics of the brain and the treatment of disease. They are using interdisciplinary knowledge to accelerate the development of devices and therapies for unmet medical needs. Their current work addresses indications such as epilepsy, stroke, Parkinson’s disease, amyotrophic lateral sclerosis, and dementia.

NeuroKey is optimized for the analysis of large data streams from implantable BCIs but can also be integrated with other acquisition devices to process data such as temperature and blood flow.?

NeuroKey is a real-time neural signal processing platform that works directly with implantable devices that acquire high channel count and high frequency brain signals. It extracts information and generates commands to control assistive devices that can help restore mobility, communication, and independence for people with paralysis or other nervous system disorders. These tiny, 3.2 x 3.2 mm, microelectrode arrays are inserted into the surface of the motor cortex – the part of the brain responsible for movement. Each array has 64 needle-like electrodes that record neural signals allowing patients to use a computer to select letters and ultimately spell words and sentences. This advanced software can handle large data streams in real time from hundreds of channels recording from the human brain.

Enabling home-use of BCIs is a priority for the NeuroKey team. NeuroKey is currently being used in a home-use study to enable communication for a person who has ALS (amyotrophic lateral sclerosis). The user-friendly graphical interface makes it easy for family members and caregivers to launch and calibrate the BCI system. As the person uses the BCI, data is collected by Wyss Center scientists. This data is used to help them improve their algorithms.

Brain activity is recorded from implantable microelectrode arrays. Each square shows the neural recorded simultaneously by each microelectrode or channel.

NeuroKey combines and processes data from BCIs and other monitoring devices in real time. This is a medical-grade platform and aims to be a complete solution that works directly with devices to collect brain signals for both research and clinical use. The software decodes intention from neural signals acquired from implanted electrodes in real-time and runs an auditory feedback speller that prompts the user to select letters to form words and sentences. NeuroKey also provides a Yes/No question option using auditory feedback to enable quick responses.

The software is modular allowing complex algorithms to be divided into smaller steps. The basic units are called processors. These independent software modules interface with external data sources, manage assistive devices, or process incoming data. Users select NeuroKey processors in the graphical user interface to easily build and interconnect their own processing pipelines.?In addition to its own default apps, which include a speller for communication, NeuroKey has an API to enable development of custom-made apps. The NeuroKey API allows full pipeline control and secure real-time access to large streams of data at every processor and can hence deliver results to third party applications.?

NeuroKey features

• Medical grade:?NeuroKey is being developed as medical software to allow fast prototyping and deployment of BCI applications in accordance with the international standard IEC 62304.
• Flexibility:?The processing blocks are customizable so they can be easily integrated into BCI applications.
• Modularity:?Users drag and drop the NeuroKey processors in the graphical user interface to build and interconnect their own processing pipeline.
• Data Integration:?NeuroKey can interface with multiple commercial or custom-made data acquisition devices and sources in a simultaneous, scalable and synchronized way.
• Developers API:?Secure, controlled access to all data generated within processing pipelines at every block and in real-time.?

Researchers and clinicians can use the NeuroKey software to combine and analyze patient data from BCIs and other monitoring devices. NeuroKey is optimized for the analysis of large data streams from implantable BCIs but can also be integrated with other acquisition devices to process data such as temperature and blood flow. NeuroKey controls devices in the clinic or at home with apps that can be refined in the platform to achieve the best results for the patient.

NeuroKey clinical use cases?

The NeuroKey software is suitable for use in the clinic or at home so has the potential to give people with paralysis a new level of independence.

• Communication?- Restore communication in completely locked-in patients by combining diverse neural and physical data sources and decoding them in real-time to enable use of a speller.
• Stroke rehabilitation?- Gather movement intention data to help reinforce neural pathways during stroke therapy.?
• Recovery from spinal cord injury?- Help restore leg movement following injury by processing multiple data streams and generating spinal cord stimulation commands.?
• Control assistive devices in the home?- Process data from multiple sources and provide command signals to activate assistive devices that help with daily activities, build independence, and improve safety and well-being at home.?

ABILITY

The Wyss Center is integrating NeuroKey with?ABILITY which stands for Active Brain Implant Live Information Transfer sYstem. ABILITY uses multiple channels to collect high-resolution brain data that are needed to effectively restore communication, movement and independence for people with disabilities.?At the center of the ABILITY platform is an active, fully implantable medical device, designed for long-term implantation. Its design brings together state-of-the-art know-how and engineering to achieve numerous ‘firsts’ in the area of brain implantable devices. Battery-less operation and encapsulation in a protective housing with hermetic sealing and biocompatible materials will allow the implant to function in the body for years. The implant is similar in size to a cochlear implant and can be implanted with a simple procedure.?

Development efforts are currently focused on the following applications:??

• Restoring reach and grasp in tetraplegia and stroke patients, in collaboration with H?pitaux Universitaires de Genève (HUG)
• Enabling communication with people ‘locked-in’ as a result of Amyotrophic Lateral Sclerosis (ALS), in collaboration with Utrecht?University
• Restoration of walking in people following spinal cord injury, in collaboration with école Polytechnique Fédérale de Lausanne (EPFL) and Centre Hospitalier Universitaire Vaudois (CHUV)
• Exploring the potential for use in neuromodulation applications?

Advances at the Wyss Center stem from the intersection of neurodevices, neuroimaging and neurobiology. These advances result in data and insights that will lead to the next generation of diagnostics and therapies and have substantial clinical impact. NeuroKey BCI for communication is medical device software of safety class A as per IEC 62304 and CE-marked as Class I as per the Medical Device Directive 93/42/EEC. CE marking indicates that a product has been assessed and deemed to meet European Union safety, health and environmental protection requirements.

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Copyright ? 2021 Margaretta Colangelo. All Rights Reserved.

This article was written by?Margaretta Colangelo.?Margaretta is a leading AI analyst based in San Francisco. She serves on the advisory board of the AI Precision Health Institute at the University of Hawai?i?Cancer Center.?

Twitter?@realmargaretta