US-based Neuralink has received approval to launch a new feasibility trial studying its brain implant linked with an assistive robotic arm.
Founded by Elon Musk, the company said that the trial, named CONVOY, will operate with cross-enrolling from the company’s ongoing PRIME study (NCT06429735), which is being completed in the US.
Neuralink did not reveal further details about the feasibility trial, adding only that it “is an important first step towards restoring not only digital freedom but also physical freedom”.
Neuralink implanted the first patient with its brain-computer interface (BCI) in January this year, after an investigational device exemption (IDE) was awarded by the US Food and Drug Administration (FDA) in May 2023. The BCI is designed to give paralysed people the ability to control external secondary devices through thoughts. They work by taking brain signals and translating them into commands, which are then relayed to a secondary, external device that carries out a specific function.
PRIME is evaluating Neuralink’s N1 implant and R1 robotic device, the latter being the technology that helps insert the brain chip’s threads into the brain’s context. It is estimated that five patients with limited or no ability to use both hands due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) will be enrolled, as per a ClinicalTrials.gov entry. Neuralink has also launched a Canadian trial, CAN-PRIME, following approval this month.
The first implant has led to viral videos of the patient playing chess on a computer using only his thoughts, along with posting on social media. However, the implant did encounter a few problems, with the device becoming partly detached from the patient’s brain. The implant’s functionality started to decline after some of the threads that connect the chip with the brain began retracting.
A second spinal cord injury patient was implanted in August this year, with Neuralink saying the participant has been playing video games and started to use 3D design software a month after the surgery. The company has not provided an update since.
Although Neuralink is capturing much of the public interest in BCIs, it is not the only company developing the technology. BrainGate has developed one of the more mature systems, having already published results in the Neurology Journal. Data indicated a good long-term safety profile and has previously shown positive proof-of-concept demonstrations.
Clinatec, a biomedical research centre in Grenoble, France, has developed a semi-invasive device that sits on the surface of the brain. In May 2023, the company published results in Nature that demonstrated its Wimagine device helped restore communication between the brain and spinal cord. As a result of the implant, a patient with chronic tetraplegia was able to stand and walk naturally. Clinatec’s device is also currently being used by Onward in trials evaluating the implant in tandem with spinal cord stimulators.
In addition, US-based Synchron, which is backed by Jeff Bezos and Bill Gates among others, completed patient enrolment in an early feasibility study for its BCI in September 2023.
