The two companies leading the charge in integrating human physiology with machinery, Neuralink and Synchron, have both entered the human clinical trials stage of research and development. Both companies aim to improve and eventually restore patients’ mobility, filling the unmet medical needs of millions of people with physical disabilities and neurological diseases.
The FDA stamp of approval to move on to clinical trials signifies that they’ve made major breakthroughs in medical technology. The medical fraternity is increasingly watching and waiting for the results from both trials and the impact they’ll have on patients’ lives.
Here’s what each clinical trial aims to achieve and where they are in the process:
Neuralink: Patient Zero
In 2016, Noland Arbaugh sustained a major spinal cord injury from a swimming incident. Paralyzed from the neck down, the former university student and athlete faced a new reality, with limited mobility, confined to a wheelchair.
In 2023, Arbaugh’s life changed again when he became the first person to receive a Neuralink chip.
With the aim to improve mobility and independence for patients with degenerative diseases, neurological disorders, and physical disabilities, Neuralink’s brain-chip interface allows users to control a computer’s cursor with their thoughts.
This opens up their world to include anything and everything that can be done online, increasing independence and boosting mental health. Patients can once again do their own grocery shopping, re-enter the labor force, connect with friends and family, and even play online games, something Arbaugh was particularly excited about.
But the implant is not without its risks.
Arbaugh experienced complications when 85% of the wires responsible for transmitting electrons became detached just weeks after the chip was implanted. He was advised against further surgery and worked with the team to retool the system.
As the first Neuralink patient, Noland is optimistic about what the company offers people with paralysis or neurological disorders. “I think it’s going to change the world,” Arbaugh said. “It’s going to change everything we know about the brain, about medicine, about diseases of the brain, about motor function. And I’m hoping that at some point, people will not have to go through what I’ve gone through. That’s my end goal of this, to make it where no one would have to live being paralyzed ever again, no one would have to live with ALS or any of the other things that they’re planning on solving with this.”
Neuralink: Expectations for clinical trials going forward
Regulatory approval is still a far thought for Neuralink; they will need to provide extensive qualitative and quantitative results before they can enter the market. In 2021, the Food and Drug Administration released a paper providing their initial assessment of brain-chip interface devices, making note of the rapid advancements in the field.
To achieve these results, they’re looking to recruit three patients for the study. Their PRIME (Precise Robotically Implanted Brain-Computer Interface) study, titled “PRIME: An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for the Control of External Devices,” will take place over several years.
Initial results have been published in the US Clinical Trials database, and the rest of the outcomes are expected in phases. The primary data set will be released in 2026, and the full study in 2031.
“Imagine if Stephen Hawking could communicate faster than a speed typist or auctioneer. That is the goal,” says Elon Musk, outlining his hopes for Neuralink’s development come 2031.
While the company is on track to meet its targeted outlines for the study, industry leaders, researchers, and regulators have criticized its lack of transparency and failure to meet industry practices by sharing research and information. This may be largely due to the fact that BCI technology is a close race, and Neuralink faces pressure from competitor Synchron.
Synchron: The Journey from Concept to Clinical Trial
Neuralink’s closest competitor is Synchron, and although they haven’t received nearly as much media attention, they’re a lot further along in their BCI development.
The company has evolved from a university-based startup to a private company backed by both Jeff Bezos and Bill Gates. They were granted FDA approval for human clinical trials in the US IN 2021, and started with implanting the device in six patients. This is in addition to the first four patients in Australia, who showed no adverse side effects.
These preliminary studies are building to a full-scale clinical trial, which Synchron is still awaiting approval for. With the early feasibility study, they aim to evaluate the safety of the endovascular brain-computer interface, as well as the efficacy of the Synchron Switch motor implant in patients with severe paralysis.
In a different approach to Neuralink, Synchron uses a stent (Strentrode™) implanted in the blood vessels of the brain. This is a revolutionary step in a rapidly evolving industry. According to Raul Nogueira, “Giving patients the option to receive a BCI device without the need for open brain surgery could open up a new frontier in BCI.” Raul is a researcher at the University of Pittsburgh Medical Center Stroke Institute, one of the institutions working on the clinical study.
The first US procedure was performed at Mount Sinai West in New York in July 2022. The team was led by clinical investigator Shahram Majidi, MD, assistant professor of neurosurgery, neurology, and radiology at the Icahn School of Medicine at Mount Sinai. Industry experts were particularly interested in the minimally invasive, endovascular approach.
“This is an incredibly exciting milestone for the field because of its implications and huge potential,” said Shahram Majidi, MD. “The implantation procedure went extremely well, and the patient was able to go home 48 hours after the surgery.”
Patients have shown incredible results with the implant and report minimal to no adverse reactions but a positive uptick in mobility, quality of life, independence, and self-esteem. For a patient like Mark, with an ALS diagnosis, declining motor function is imminent. But, as he points out, while his motor neurons may be malfunctioning, his brain certainly isn’t. This is what makes BCI technology a key to unlocking boundless possibilities for millions of people like Mark.
COMMAND Trial: What Comes Next
The procedure marks the first US patient implant in Synchron’s COMMAND trial, which is being conducted under the first investigational device exemption (IDE) awarded by the FDA to a company assessing a permanently implanted BCI. The US-based trial is being conducted with support from the NIH Neural Interfaces Program.
The COMMAND study will evaluate the safety and efficacy of the company’s software for BCI and Stentrode. The study aims to implant the device in patients with severe paralysis, with the goal of enabling the patient to control digital devices hands-free. Study outcomes include using brain data to control digital devices and achieving improvements in functional independence.
The Stentrode is implanted within the motor cortex of the brain via the jugular vein in a minimally invasive endovascular procedure. Once implanted, the device detects and transmits actions using a proprietary digital language. This allows patients to control personal devices with hands-free point-and-click. The trial will assess the impact of everyday tasks such as texting, emailing, online shopping, accessing telehealth services, and the ability to live independently.
The COMMAND study is being conducted and coordinated at three US clinical sites: Mount Sinai Health System in New York City, University at Buffalo Neurosurgery in Buffalo, and UPMC—in collaboration with Carnegie Mellon University College of Engineering—in Pittsburgh. It is being carried out with support from the National Institutes of Health (NIH) BRAIN initiative.
“We would like to thank everyone who partnered with us to complete this important clinical trial enrollment milestone, especially patients and caregivers as well as the physicians and research staff at our clinical sites in the USA,” said Tom Oxley, CEO and founder of Synchron. “We look forward to announcing the results from our COMMAND study and will continue to advance the development of Synchron Switch towards a pivotal clinical trial in the USA.”
BCI Human Trials: Balancing Risk and Reward
Neuralink and Synchron represent a breakthrough in medical science. Patients, previously resigned to a life with little to no independence or convenience, have hope for a future of improved mobility and less reliance on caregivers.
But with these advancements comes the immense concern for the risks. Here are just a few of the areas that both Neuralink and Synchron will have to work on:
- Physical risks associated with brain surgery
For Neuralink specifically, the implantation procedure is fraught with risks. Brain surgery carries a significant risk of infection, bleeding, and damage to brain tissue. Synchron has the upper hand with this particular issue as they use a minimally invasive endovascular implantation process that carries little risk. - Unknown long-term risksBoth Neuralink and Synchron had an extensive animal testing period before embarking on human trials. During this process, Neuralink raised concerns in the community about how these tests were conducted, with animal deaths being “higher than they need to be”. Questions about the possible long-term effects of having a Neuralink brain implant are pertinent. This could include changes in cognition, personality, or mood, among other potential effects. The same is true of Synchron, who only have data up to one year which reports that the device stayed in place and that no adverse reactions were recorded in patients.
- Privacy and data security issues
Both companies collect a significant amount of raw data about an individual’s brain activity. This raises concerns about who would have access to this data and how it would be protected. - Potential social inequalities
If Neuralink and Synchron become widely used and beneficial, there’s a risk of creating technology access inequalities based on affordability.
These companies are considering the risks while on a mission to meet the needs of people with neurological and physical diseases and disabilities. They have the potential to treat various medical conditions, such as epilepsy, Parkinson’s disease, ALS, and paraplegia, by altering neuronal activity in specific ways.
- Restoration of sensory and motor functions
Neuralink and Synchron aim to restore motor functions in people with spinal cord injuries or diseases causing paralysis. This could give people the ability to move and feel again, significantly improving their quality of life. - More efficient brain-computer interfaces
Both companies have developed implants that could enhance brain-computer communication, benefiting individuals with disabilities and fostering innovative technology interactions. - Advancements in neuroscience research
With the vast amounts of data, Synchron and Neuralink’s technology could provide a valuable research tool in neuroscience, allowing scientists to study the human brain with an unprecedented level of detail.
Concluding Thoughts
The next few years will be important for both Neuralink and Synchron, and potential patients will be waiting with bated breath for their products to become commercially available. But, experts caution that there’s still much to be done before the FDA approves this.
As it stands, Neuralink seems to have their work cut out for them if they plan to catch up with Synchron and become the market leader. Synchron has already generated a long-term study in Australia with four patients who have the Stentrode implanted and is well on its way to establishing similar results in the US, with six patients enrolled in the COMMAND trial.
What is certain is that two companies with the resources of some of the world’s richest men are likely to catapult neuroscience research within the next few years. Their devices are able to capture and process brain activity in a way that’s never been done before, and at the same time, are offering a new way of life for patients facing degenerative motor neuron diseases and paralysis.
