Neuralink officially opened recruitment Tuesday for its first-in-human clinical trial to implant a wireless chip into the brain that could allow the person to control bodily movements with only their thoughts.
It’s a win for Neuralink’s co-founder and tech billionaire Elon Musk, who has been enticing the media – and those suffering from severe paralysis – about the possibility of human test trials since at least 2019.
Neuralink announced it had received the go-ahead from an independent institutional review board to begin the first-ever trial, the final step needed since it obtained approval from the US Food and Drug Administration (FDA) this past May.
The California-based neurotechnology firm posted the news on its website and X (formally known as Twitter) Tuesday afternoon to a fanfare of likes, comments, and views.
Part of the review board decision also involved approving the first hospital site chosen by Neuralink to conduct what it is calling the "PRIME Study,” also known as Precise Robotically Implanted Brain-Computer Interface.
There was no information provided about the 'first hospital' chosen nor a short list of other hospitals that may be considered to partake in the experimental surgery down the line, but the company did say travel and other costs associated with the trial will be covered for participants.
The “groundbreaking investigational medical device trial” will implant the wireless brain-computer interface (BCI) with the goal of both evaluating the safety of the implant (N1) and the surgical robot (R1), Neuralink said in the announcement.
The trials will also “assess the initial functionality of our BCI for enabling people with paralysis to control external devices with their thoughts,” it said.
The expected six-year-long trial will start with a surgical robot implanting the device using ultra-fine and flexible threads in the region of the human brain that controls movement intention.
If all goes as planned, the device will be able to “record and transmit brain signals wirelessly to an app that decodes movement intention.”
The next phase would determine if the test subject would then be able to control a computer cursor or keyboard with their thoughts, ultimately with the goal of translating thought into physical movement – and giving hope to those with permanent spinal cord injuries or diseases for the first time in their lives.
“The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone,” stated Neuralink.
Musk said in June that the surgery will be streamed via a webcast monitored by the Reuters news organization.
Hope for Spinal Cord Injuries and Diseases
According to the World Health Organization, between 250,000 and 500,000 people worldwide suffer a spinal cord injury (SCI) each year.
In the United States alone, only 1% of those with traumatic SCI fully recover. Most will suffer partial or full paraplegia or quadriplegia with a reduced life span.
For those with neurodegenerative spinal diseases such as amyotrophic lateral sclerosis (ALS), approximately 5,000 people in the US are diagnosed each year, according to ALS News Today.
“This is a significant milestone in the field of brain-computer interfaces (BCIs). BCIs have the potential to revolutionize the way people with paralysis interact with the world around them,” posted X user @Just_intellect.
Meantime, Musk’s initial bid to gain FDA approval was rejected in 2022 over safety issues, including the device’s lithium battery, possible wire migration into brain tissue, and implant removal.
Musk and Neuralink have also been investigated by US officials over claims of animal abuse violations, transportation of dangerous pathogens, and possible SEC violations due to stakeholder conflicts of interest.
Experts say even if Neuralink can prove its device is safe for humans, it would still most likely take more than a decade to clear the FDA for commercial use.
Unfortunately for some, that will already be too late. X user @JohnsonNJiiina posted about the heartbreak of knowing those suffering with the disease.
“My younger cousin was a quadriplegic due to a serious cervical spinal cord injury; always full of vibrance/optimism, but unfortunately passed before a day like this. Jesse always believed it would arrive sooner or later...I wish he could be reading this post today.”
Neuralink said the trial is open to patients with quadriplegia due to a spinal cord injury or those with ALS.
The applicants have 22 years or up and at least one year post-op without improvement to qualify.
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