Neuralink, the neurotech startup owned by Elon Musk, recently announced that it will begin recruiting patients for its first-in-human clinical trial. The trial, called PRIME Study (Precise Robotically Implanted Brain-Computer Interface), aims to evaluate the safety of Neuralink’s fully- implantable, wireless brain-computer interface (BCI). The study is looking for people with quadriplegia due to spinal cord injury or amyotrophic lateral sclerosis (ALS). The trial has been approved by the FDA and an independent review board.
The Neuralink BCI is a small, implantable device that contains thousands of flexible threads that are inserted into the brain. The threads are connected to a chip that reads and writes neural signals. The device is powered by a small battery implanted under the skin behind the ear.
During the study, the ultra-fine and flexible threads of the N1 implant are surgically placed in a brain region that controls movement intention using the R1 robot. Once placed, the N1 implant is cosmetically invisible and is intended to record brain signals and wirelessly transmit them to an app that decodes movement intention. The initial goal of Neuralink’s BCI is to enable people to control a computer cursor or keyboard using their thoughts alone. The study will evaluate the safety of the Neuralink implant by monitoring participants for potential adverse effects such as infection or inflammation. It will also assess the feasibility of the device by measuring how well participants are able to use it to control external devices.
The first-in-human clinical trial of Neuralink raises a number of ethical considerations. One concern is that the trial may involve too much risk for participants. The Neuralink BCI is a complex device that has never been implanted in a human before. There is a risk that the surgical procedure to implant the device could cause serious complications, or that the device itself could malfunction. Another concern is that participants in the trial may be pressured to agree to participate even if they are not fully informed of the risks and benefits. It is important that participants are able to make a voluntary and informed decision about whether or not to participate in the trial.
There are also ethical concerns about the potential future use of Neuralink’s BCI device. For example, the device could be used to track people’s thoughts and emotions without their consent. In the event that Neuralink’s BCI device is widely used, it is imperative that safeguards be put in place to protect people’s privacy and autonomy.
Neuralink’s BCI device could soon be available to people with quadriplegia and ALS if the PRIME Study is a success. The company is also developing the device for other uses, such as restoring vision and enabling direct communication with computers using thoughts. This would be a major breakthrough for people with neurological disorders and for the field of neurotechnology.