PRIME Study
Neuralink's first-in-human trial of a thought-controlled brain implant for paralysis
The PRIME Study is Neuralink's first trial in humans, a test of whether a coin-sized brain implant can let a person with severe paralysis control a computer or a phone by thought alone. PRIME stands for Precise Robotically Implanted Brain-Computer Interface. Its first participant, implanted on January 28, 2024, learned to move a cursor just by intending to move it, and the very next day Elon announced the product had a name: Telepathy.
The first human received an implant from @Neuralink yesterday and is recovering well. Initial results show promising neuron spike detection.
— Elon Musk (@elonmusk) See the post on X
What is the PRIME Study?
PRIME is an early feasibility study registered with the United States National Library of Medicine as NCT06429735. It tests two pieces of hardware together: the N1, a coin-sized implant that reads brain activity, and R1, the surgical robot that places it. A brain-computer interface (BCI) is a system that turns brain signals directly into commands for a device. The N1 carries 1,024 electrodes spread across 64 threads, each thinner than a human hair, all listening to the motor cortex, which is the part of the brain that forms the intention to move.
Why the PRIME Study Exists
The trial is built for people with quadriplegia, meaning paralysis in all four limbs, caused by a neck spinal cord injury or by amyotrophic lateral sclerosis (ALS, a progressive disease that destroys the nerves that control muscle). Participants must be at least one year past their injury with no improvement, and at least 22 years old. For these people, even one mouse click is out of reach. The United States Food and Drug Administration (FDA) granted the Investigational Device Exemption (IDE) that legally permits the trial in May 2023, and recruitment opened that September. The goal is simple to state: read the intention to move from the brain, and hand it back as control on a screen.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our
— Neuralink (@neuralink) See the post on X
How it Works
The R1 robot places the threads with a precision no human hand can match. The N1 then reads the firing of individual brain cells and turns the user's intended movement into cursor motion. Speed is measured in bits per second (BPS), a unit that captures how much thought-to-action information flows each second. During his first research session, the first participant set a world record for BCI cursor control at 4.6 BPS, then later reached 8.0. A different participant went on to top 10. On October 1, 2026 Neuralink reported a new BCI record of 11.32 BPS, with the median participant at about 10. Typing has reached up to 40 words per minute.

Early progress with our second participant https://t.co/uiFVAUZzvK
— Neuralink (@neuralink) See the post on X
The Economics of the PRIME Study
The N1 implant, the R1 robot, and the companion app are investigational devices, and Neuralink covers the device, the surgery, and study travel for each participant and a caregiver. What stands in for revenue is the surgical record: Neuralink performed 1 implant in the first half of 2024 and 13 in the second half of 2025. As the robot takes on more of the work, the cost and effort of each surgery can fall, which is how a future product would eventually pay for its development.
Current Status of PRIME Study
By the two-year mark on January 28, 2026, Neuralink reported 21 enrolled participants, whom it calls Neuralnauts, and zero serious device-related adverse events. Neura Pod counts 27+ people as of October 2026: about 16 in the United States, 7 in the United Kingdom, and 4 in Canada. One participant logged as much as 17 hours of use in one day. The program spans 4 countries: the United States, Canada, the United Kingdom, and the United Arab Emirates, where the Abu Dhabi site has not reported an implant yet.
What Comes Next
PRIME's 18-month main phase is followed by a 5-year safety follow-up, which puts the full study near six years. It has already branched out. CONVOY tests N1 control of a helper robotic arm, and VOICE aims to restore speech, with a stated conversational goal of 140 words per minute. The international versions (CAN-PRIME, UAE-PRIME, and GB-PRIME) open access well beyond the original American sites. Each spinoff is a fresh test of what one implant can read, and each one adds follow-up care and software around a small but growing group of users.
The Bottom Line
PRIME has shown, with a real surgical record rather than a promise, that a wireless, high-channel implant can hand digital control back to people who had lost it. Decoding keeps getting faster: the cursor record rose from 4.6 bits per second in 2024 to 11.32 in October 2026.
Timeline
- 2023 May: The FDA grants Neuralink an Investigational Device Exemption (IDE) for the PRIME Study.
- 2023 September 19: Recruitment opens and the patient registry launches.
- 2024 January 28: The first participant receives the N1 Implant at Barrow Neurological Institute.
- 2024 January 29: Elon Musk announces that the first product is called Telepathy.
- 2024 May 8: Neuralink reports that its first participant set a 4.6 bits-per-second cursor record in an earlier session and later reached 8.0.
- 2024 November: The CAN-PRIME (Canada) and CONVOY (robotic arm) trials begin.
- 2025 May: UAE-PRIME begins at Cleveland Clinic Abu Dhabi, and the FDA grants a Breakthrough Device Designation for speech.
- 2025 July: GB-PRIME begins in London and Newcastle.
- 2025 October: VOICE begins at UT Southwestern in Dallas.
- 2026 January 28: Neuralink's "Two Years of Telepathy" update reports 21 enrolled participants and zero serious device-related adverse events.
- 2026 May 20: Surgeons in Toronto implant Lee Marten through the dura, the brain's tough outer membrane, without opening it, a first for Neuralink.
- 2026 October 1: Neuralink reports a new cursor record of 11.32 bits per second, with the median participant at about 10.
Sources (16)
- Neura Pod: Neuralink patient table (October 2026)
- Neuralink's First-in-Human Clinical Trial is Open for Recruitment
- Neuralink: PRIME Study Progress Update - User Experience
- Neuralink: "Two Years of Telepathy" (January 28, 2026)
- Neuralink: Clinical trials
- Neuralink: PRIME Study Brochure (PDF)
- ClinicalTrials.gov: PRIME: An Early Feasibility Study (NCT06429735)
- ClinicalTrials.gov: CAN-PRIME (NCT06700304)
- ClinicalTrials.gov: CONVOY (NCT06710626)
- ClinicalTrials.gov: UAE-PRIME (NCT06992596)
- ClinicalTrials.gov: GB-PRIME (NCT07127172)
- ClinicalTrials.gov: VOICE (NCT07224256)
- Neura Pod: Neuralink clinical trial sites
- Neura Pod: Lee Marten, the first through-the-dura implant (May 20, 2026)
- Elon Musk on X: post announcing Telepathy
- Neuralink: "Pretraining on 50,000 Hours" (October 1, 2026)
