Key TakeawaysElon Musk’s neurotechnology startup, Neuralink, is recruiting for its first human trial.The FDA granted the company approval for human testing in May 2023 after rejecting its application last year, citing safety concerns.Neuralink will test the safety and feasibility of its brain implant, and it hopes to help patients with paralysis control a keyboard or computer cursor with their minds.

Key Takeaways

Elon Musk’s neurotechnology startup, Neuralink, is recruiting for its first human trial.The FDA granted the company approval for human testing in May 2023 after rejecting its application last year, citing safety concerns.Neuralink will test the safety and feasibility of its brain implant, and it hopes to help patients with paralysis control a keyboard or computer cursor with their minds.

Elon Musk’s biotechnology startup, Neuralink, recently announced that it’s recruiting volunteers for its first human trial of brain implants for patients withparalysis.

The company said on X that people who havequadriplegia(both arms and legs are paralyzed) due to cervical spinal cord injury oramyotrophic lateral sclerosis (ALS)may qualify.

During the trial, a surgical robot will place a brain-computer interface (BCI) impact in the part of the brain that controls movement intention. The goal is for people with paralysis to control a keyboard or computer cursor with their minds, according to aNeuralink blog post.

The implant is the “size of a large coin” and is similar to “a Fitbit in your skull with tiny wires,” Musk said during 2020Neuralink progress update presentation.

While Neuralink’s device may sound like science fiction, neuroscientists have been developing this type of technology since the 1970s.In 2016, a paralyzed man used BCI to control a robotic arm for ahistoric fist bumpwith President Barack Obama.

Paralyzed Patients Are Walking Again After Spinal Cord Stimulation

Last year, the Food and Drug Administration (FDA) rejected Neuralink’s first application for human trials, citing safety concerns such as the “potential for the implant’s tiny wires to migrate to other areas of the brain,” according toReuters.

However, Neuralink received approval in May 2023 to move forward with human trials.

“No monkey has died as a result of a Neuralink implant,” Musk said on X. “First our early implants, to minimize risk to healthy monkeys, we chose terminal moneys[sic](close to death already).”

A major risk of the brain implant in humans is infection, according toKiminobu Sugaya, PhD, a professor of medicine and head of neuroscience at the University of Central Florida.

“This device sits on the surface of the brain, but still, it may cause some inflammation, immune response, although that could be minimum,” Sugaya told Verywell.

Neuralink did not respond to Verywell’s request for comment.

The Neuralink trial, calledThe PRIME Study(Precise Robotically Implanted Brain-Computer Interface), will specifically assess the safety and functionalityof the device and the robot that is making the surgical implant.

“It’s always great to hear that some good quality research is going to occur and we will watch the research with interest to see if it can be of utility to our patients,” saidDavid Putrino, PhD, a neuroscience expert and director of rehabilitation innovation for the Mount Sinai Health System.

As the Neuralink study progresses, it will be important to monitor the number of minor and major adverse events that occur related to the technology, the risk of infection, and observe if the device can be safely implanted and removed, Putrino said.

Neuralink’s PRIME study will takesix yearsto complete. Putrino said if the trial is successful, the next step would be for Neuralink to conduct a “pivotal” trial to show that the device improves people’s quality of life and their ability to advocate for themselves.

“I’m cautiously optimistic,” Putrino said. “I don’t want to fill people with severe disability with false hope that this is going to be a technology that’s available for them tomorrow. These trials will take years and it’s important that they’re done right and it’s important that they’re done carefully.”

What This Means For YouExperts say it will be years before Neuralink’s device is ready for clinical use. This startup is just one of a few BCI companies that are working to create a safe and effective version of this neurotechnology.

What This Means For You

Experts say it will be years before Neuralink’s device is ready for clinical use. This startup is just one of a few BCI companies that are working to create a safe and effective version of this neurotechnology.

1 SourceVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Kawala-Sterniuk A, Browarska N, Al-Bakri A, et al.Summary of over fifty years with brain-computer interfaces—a review.Brain Sciences. 2021;11(1):43. doi:10.3390/brainsci11010043

1 Source

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Kawala-Sterniuk A, Browarska N, Al-Bakri A, et al.Summary of over fifty years with brain-computer interfaces—a review.Brain Sciences. 2021;11(1):43. doi:10.3390/brainsci11010043

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Kawala-Sterniuk A, Browarska N, Al-Bakri A, et al.Summary of over fifty years with brain-computer interfaces—a review.Brain Sciences. 2021;11(1):43. doi:10.3390/brainsci11010043

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