Neuralink launches brain-computer interface trial for people with paralysis

Neuralink, the brain-technology company co-founded by Elon Musk, has announced the launch of the PRIME Study, a clinical trial for its fully implantable, wireless brain-computer interface (BCI). The trial aims to evaluate the safety of its N1 Implant and R1 surgical robot, while testing the ability of the BCI system to help individuals with quadriplegia control external devices like computers and smartphones using their thoughts.
The brain technology startup company said the N1 Implant is a tiny, invisible device surgically placed in the brain area responsible for movement planning. By decoding neural activity, it allows users to operate devices without physical movement or wires. Neuralink’s R1 Robot ensures precise implantation of the device, which features 1,024 electrodes across ultra-thin threads to capture brain signals.
The trial, classified as a first-in-human study, will assess the safety and effectiveness of the system, including the N1 User App software. The research targets people aged 22 and older with quadriplegia caused by cervical spinal cord injury or amyotrophic lateral sclerosis (ALS), provided their condition has remained stable for at least a year.
Participants will engage in an 18-month primary study involving at-home and clinic visits, followed by a five-year monitoring phase. Research sessions, lasting an hour twice a week, will test the BCI’s functionality.
To ensure safety, individuals with implanted devices like pacemakers, a history of seizures, or ongoing conditions requiring MRIs are excluded. Regular follow-ups during the study will monitor participants’ progress and the system’s performance.
Participants will receive compensation for study-related expenses, including travel costs. Neuralink emphasizes that its devices remain investigational and are not for sale.
The PRIME Study represents a step toward restoring autonomy for individuals with severe physical disabilities. If successful, the technology could revolutionize assistive devices and pave the way for advanced applications of brain-computer interfaces.
Neuralink’s efforts aim to bridge the gap between neuroscience and technology, offering a glimpse of a future where the human mind seamlessly interacts with machines.
Neuralink, co-founded by Elon Musk, is advancing its experimental brain-computer interface (BCI) technology. This involves a chip implanted by a surgical robot, connected to the brain by threads, enabling users to control devices like computers and smartphones with their thoughts.On August 21, the company announced a breakthrough with the successful implantation of its Link device in its second participant. The recipient achieved impressive results, setting a world record for brain-computer interface cursor control on their first day and swiftly engaging in tasks like playing Counter-Strike 2 and using CAD software.
Neuralink also highlighted progress in resolving previous technical issues, such as thread retraction problems seen in the first participant. These challenges, the company said, were addressed in the new implant, leading to more stable performance and improved functionality.