Synchron’s BCI Implants: Unlocking the Power of Connection for Paralyzed Patients

Dr. Tom Oxley of medical device startup Synchron is focused on using brain-computer interface technology to restore agency and autonomy to patients, rather than for frivolous purposes. With thousands of Americans living with conditions like ALS or spinal cord paralysis, losing access to their smartphones and independence, the need for this technology is evident.

Synchron made history by successfully implanting a BCI into a human patient through a minimally invasive procedure involving the jugular vein. This Stentrode device, placed near the motor cortex, provides better signal fidelity without the drawbacks of traditional probe arrays. The goal is to provide digital independence to those with severe disabilities, allowing them to communicate and alert caregivers in critical situations.

The potential of BCIs to enhance communication for locked-in patients is promising, with the goal of obtaining market approval within the next five years. The scalability of this technology will depend on access to facilities across the country, bringing us closer to a future where those with disabilities have versatile and continuous digital control.
In 2021, Synchron conducted the SWITCH safety study for the Stentrode device, implanting it in four ALS patients and monitoring their health over a year. The study concluded that the device was safe and remained in place without complications. Encouraged by these results, Synchron launched the COMMAND study, involving the brain.io system in six patients to enhance digital communication and improve their quality of life.

Dr. Putrino expressed surprise at the overwhelming interest in the trials, especially considering the permanent nature of the procedures and the impact on patients’ remaining years. Patients with end-stage ALS or spinal cord injuries faced significant decisions about participating in the trial and the long-term implications of the implant. Despite these challenges, the high public interest led to expedited surgeries, with the final patient undergoing implantation ahead of schedule.

Ensuring Progress and Safety

While Synchron continues the study to meet safety standards and gather more data, there is a focus on avoiding past issues like the Argus II SNAFU. The team remains committed to advancing BCI technology and providing valuable insights for the future, ensuring that patients with disabilities have access to innovative solutions for improved communication and autonomy.

The Ethical Dilemma of Brain-Computer Interfaces

However, this approach “is not sufficient and that, given BCIs’ potential influence on individuals and society, the nature of what is safe and effective and the balance between risk and benefit require special consideration,” argued a 2021 op-ed in the AMA Journal of Ethics. “The line between therapy and enhancement for BCIs is difficult to draw precisely. Therapeutic devices function to correct or compensate for some disease state, thereby restoring one to ‘normality’ or the standard species-typical form.” But what, and more importantly who, gets to define normality? How far below the mean IQ can you get before forcibly raising your score through BCI implantation is deemed worthwhile to society?

The Need for New Regulatory Measures

The op-ed’s authors concede that “While BCIs raise multiple ethical concerns, such as how to define personhood, respect for autonomy, and adequacy of informed consent, not all ethical issues justifiably form the basis of government regulation.” The FDA’s job is to test devices for safety and efficacy, not equality, after all. As such the authors instead argue that, “a new committee or regulatory body with humanistic aims, including the concerns of both individuals and society, ought to be legislated at the federal level in order to assist in regulating the nature, scope, and use of these devices.”