Synchron Announces Positive Results from U.S. COMMAND Study of Endovascular Brain-Computer Interface

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In a major step forward for next-generation implantable BCI devices, Synchron has just announced positive safety results from their COMMAND clinical trial, reporting no serious adverse events in brain/vasculature of the 6 patients enrolled over 12 months!  Impressively, surgeries had a median deployment time of 20 minutes, demonstrating a major advantage of the Stentrode technology.  And importantly, the trial demonstrated efficacy, showing that motoric brain activity was captured and transformed to digital control signals.

The Synchron system is a great example of thinking outside of the box to go beyond the current state of the art and enable BCI systems to be potentially safer, longer lasting, and easier to deploy.  The future of BCI is arriving and will be made possible by next generation technologies, whether it is novel electrodes like the Stentrode or improvements in wireless implantable technologies, such as those being advanced by our B-CRATOS project, among others.

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B-CRATOS at the Annual Meeting of the Society for Neuroscience 2024

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In October 2024, our partners from DPZ participated at the Society for Neuroscience in Chicago. It was a great opportunity for them to share their research and experience with scientists from all over the world.

The poster they presented was Training of real-time robotic grasp decoding from neuronal population activity in macaque motor cortex (M1). It concerned with the primate cortex which can be viewed as a closed-loop dynamical system with very high dimensionality. Extracting a sub-sample of this activity and using it for the decoding of any encoded intention is a challenging task by virtue of the size of the sample relative to the full population. The problem is amplified by the brain’s plasticity, which renders any effort towards decoding ephemeral.

Here they employed a modified Kalman filter to decode the grip of a robotic hand from population spiking activity recorded from two 64 channel Utah arrays implanted in the hand area of primary motor cortex (area M1) of a macaque monkey. Their results confirm that a modified Kalman Filter is suitable to successfully translate cortical activity to motor commands of a robot hand in real time. They also demonstrate the gradual learning by observation and internalization of the task by the monkey using two metrics – the reduction in the transitory nature of the decoder and the speed of the transfer of control of the prosthesis to the monkey. In early experimental sessions, the monkey was slow to take over control and the decoder required retraining within the experiment session, whereas in later sessions decoder training was required only at the beginning of the session and transfer of control was rapid. Furthermore, decoder training involved not only the training of the decoder on the neural activity, but it also adapted brain activity on the decoder, and an equilibrium had to be maintained between the learning processes. This equilibrium was achieved faster and maintained more robustly as the monkey became more proficient in the task, hence demonstrating the viability of this learning-by-observation paradigm.

Disruptive B-CRATOS approach

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We are thrilled to share with you a short teaser about B-CRATOS!

Electrode engineers are pushing channel count and density of modern implantable electrodes by orders of magnitude, but today’s BCI systems are unprepared to handle this volume of data.  Current day implantable neural interfaces already sacrifice both the quantity and quality of data collected, largely due to constraints on wireless data transmission, due to reliance on technologies such as Bluetooth or inductive coupling.  Additionally, users of these devices often risk surgical complications or infection due to the implanted wires and batteries needed to transmit data and provide sufficient power.

The B-CRATOS neural bypass platform technologies look to address these challenges to enable future BCI to unleash the full power of the user’s brain power.  Utilizing the novel B-CRATOS in-body and off-body wireless technologies, a BCI system can now capture and transmit BIG DATA neural recordings, effectively leveraging high density electrode technologies and capturing fine-grained changes in neural activity.  And as a result, future BCI users will not only be able to “point and click”, but take advantage of the most effective algorithms to control complex prosthetics, decode speech, or meet other everyday needs.  Detection routines for closed-loop stimulation devices will not be limited to monitoring biomarkers on a small handful of channels at low sampling rates.  And critically, B-CRATOS technologies reduce the need for implanted wires and bulky batteries, which promotes user safety, system longevity, and ultimately adoption of the devices to make a positive impact on human health and quality of life.

 

 

The state of clinical trials of implantable Brain–Computer Interfaces

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BCI Pioneer (and 2024 B-CRATOS Webinar participant) Ian Burkhart has recently co-authored a comprehensive review of clinical trials for implantable BCI in Nature Reviews Bioengineering!

Importantly, Ian and his co-authors not only review the history of BCI trials, but provide valuable insights regarding a pathway forward regarding patient ethics, a need for BCI standards, diversity in recruited volunteers, and other needs/barriers for progress.  The truly leave no stone unturned in covering everything from patient participants to research groups to technologies to the practicality of future clinical products.

And given Ian’s unique position as a former implantable BCI study participant, such perspective is invaluable for the field.  We expect this review to be a core resource for those wishing to better understand the history, present, and future of the field.

The review nicely compiles a list of emerging electrodes as of December 2023, and one notes the ever-growing number of data channels these devices aim to collect.  One can imagine that with multiple such devices implanted, we will see exponential increases in the amount and complexity of data collected in BCI of the future.   To take advantage of the full potential of such data, we will need next-generation wireless technologies capable of transmitting it for analysis and storage.  At B-CRATOS, we aim to develop such technologies to bring big data BCI systems to impactful real-world applications through improved integration within the body and to devices outside of it.  We also expect that by developing next-gen wireless technologies for implantable systems, patient acceptance, usability, and safety can be greatly improved over current systems.

 

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