Gary Zhou 
Key Points
- 💡 Neuralink has received approval to conduct human clinical trials for its brain implant technology.
- 🧠 The clinical trial is called the PRIME study, focusing on enabling people with paralysis to control external devices using brain-computer interfaces (BCI).
- 🏥 An independent review board and a hospital site have granted approval for the clinical trials, and Neuralink has an FDA investigational device exemption.
- 🧑🤝🧑 Potential candidates for the trial must have quadriplegia due to spinal cord injury or ALS, be at least a year post-injury without improvement, and have a consistent caregiver.
- ❌ Excluded candidates include those with active implanted devices, a history of seizures, or the need for ongoing MRIs or transcranial magnetic stimulation treatment.
- 🤖 Neuralink plans to use a surgical robot to implant ultra-fine threads in the brain to monitor and transmit signals, allowing control of external devices with thoughts alone.
- 🐒 Neuralink has faced criticism for animal treatment in early trials, but the company denies related claims.
- 💰 Neuralink’s value was reported to be approximately $5 billion, but it may take another decade for its brain implant to become commercially viable.
Elon Musk’s company Neuralink has been approved to begin human clinical trials for its brain implant technology.
Neuralink shared the news on its website on Tuesday, announcing the PRIME study, which is short for “Precise Robotically Implanted Brain-Computer Interface,” according to the company. The study’s initial goal is to use the implants to enable people with paralysis to control external devices such as computer cursors or keyboards.
An independent institutional review board and a hospital site have both approved Neuralink to begin clinical trials of the brain-computer interface (BCI), and the company has begun recruiting for the study. The company will also be operating under an investigational device exemption (IDE), which the Federal Drug Administration (FDA) granted to the company in May.
According to Neuralink, potential candidates for the trial include those with “quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS),” and they must be at least a year post-injury without improvement. Participants must also be 22 or over and have a consistent and reliable caregiver.
Interested parties are encouraged to join the company’s patient registry.
In a brochure detailing the study, Neuralink writes that it can’t accept those with the following:
- active implanted devices like pacemakers or deep brain stimulators (DBS)
- a history of seizures
- required MRIs for ongoing medical conditions
- ongoing transcranial magnetic stimulation (TMS) treatment
Neuralink calls the PRIME trial a “groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI) – [which] aims to evaluate the safety of our implant (N1) and surgical robot (R1) and assess the initial functionality of our BCI for enabling people with paralysis to control external devices with their thoughts.”
The company says it will use its surgical robot to place the implant’s ultra-fine, flexible threads into a region of the brain controlling movement intention. Then, the implant will be used to monitor and transmit brain signals to an app, which would decode movement intention.
“The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone,” writes the company on its website.
Neuralink has faced criticism for its treatment of animals in early trials, though Musk has continually denied related claims. In recent weeks, Musk denied allegations that several monkeys with Neuralink implants died, adding that terminally ill monkeys had been chosen for the company’s first implants to avoid risks to healthy monkeys.
In June, sources citing privately executed stock trades reported to Reuters that Neuralink was worth roughly $5 billion. Still, some think it could take another decade for the company’s brain implant to become a commercially viable product.
