What Is Neuralink's PRIME Study? Essential Details Revealed

• Neuralink's PRIME Study is a first-in-human clinical trial that tests the safety and function of the company's N1 brain implant and R1 surgical robot for adults with quadriplegia caused by spinal cord injury or ALS.
• The study lets participants control computers by thought by implanting 1,024 electrodes on 64 threads (128 thinner threads in later implants) into the brain's motor cortex.
• PRIME runs at Barrow Neurological Institute and the University of Miami, with sister studies in Canada and the UK and a UAE site recruiting.

Overview of the PRIME Study

PRIME stands for Precise Robotically IMplanted Brain-Computer Interface. The FDA cleared it in May 2023, recruitment opened in September 2023, and the first implant took place in January 2024. It is an early feasibility study, meant to show the initial safety and basic performance of the N1 implant, a coin-sized, fully implantable device, and the R1 robot that inserts its threads.

The goal is to restore digital independence for people who cannot use their hands. Participants move cursors, click, scroll, and type through neural signals alone. Elon Musk calls this product "Telepathy." Neuralink has submitted findings from its first three participants to the New England Journal of Medicine for peer review.

The study's ClinicalTrials.gov record (NCT06429735) lists an estimated enrollment of 15 participants at Barrow and the University of Miami. Primary outcomes measure device-related and procedure-related adverse events at 12 months after implant, with secondary goals covering how well the device works for everyday tasks.

Who can join

Eligibility for PRIME centers on adults aged 22 to 75 with severe quadriplegia from spinal cord injury or ALS lasting at least 1 year without improvement, plus a stable caregiver. Candidates must be able to give informed consent and communicate reliably.

Applications go through Neuralink's patient registry at neuralink.com/trials. Selected applicants then have medical evaluations, including neurological exams and imaging. Early enrollees include Noland Arbaugh, the first recipient, from Yuma, Arizona, who now multitasks on his computer, and Army veteran RJ Tanner, implanted at the University of Miami in April 2025.

The procedure and technology

The surgery is done under general anesthesia. After the neurosurgeon removes a small disc of skull, the R1 robot inserts the threads, each thinner than a human hair, into the motor cortex. The N1 implant fills the opening and charges wirelessly.

After surgery, the implant streams neural data over Bluetooth to the participant's computer, where machine learning turns intentions into actions. Over-the-air updates improve performance. Many of the first patient's threads retracted in 2024, and software changes restored and then improved his performance. Patients can start using the system within hours, as the UK's first GB-PRIME participant did; Neuralink announced his implant on October 27, 2025.

Results so far

Arbaugh plays chess, designs 3D models, and makes calls on his own. The second participant, Alex Conley, uses CAD software and plays games. Participants now reach a median of about 10 bits per second on Neuralink's cursor test, with a record of 11.32 bits per second, according to Neuralink's October 2026 update. Neuralink reported zero serious device-related adverse events as of January 2026. Neuralink's roadmap called for about 3,000 channels in 2026, and a 3,000-channel implant was disclosed in September 2026.

Expansion and the path to approval

The University of Miami joined as a second U.S. site, with its first implant in April 2025. Internationally, GB-PRIME launched on July 31, 2025, at University College London Hospitals, CAN-PRIME gained Health Canada approval, and UAE-PRIME is recruiting at Cleveland Clinic Abu Dhabi.

Neuralink had 13 participants by October 28, 2025, and reported 21 on January 28, 2026. Device trials move from early feasibility to a pivotal study, and no Neuralink pivotal study has been posted as of October 2026. Internal projections reported by Bloomberg in 2025 targeted approval of the Telepathy device by 2029.

This article was first published in October 2025 and corrected in October 2026; the latest patient count is on the patient table.