PRIME, CONVOY and VOICE clinical trials explained: protocols, enrollment and endpoints
Neuralink evaluates its investigational N1 implant and R1 surgical robot through three distinct clinical study programs: PRIME (NCT06429735) for wireless computer control, CONVOY for assistive robotic arm and physical device control, and VOICE (NCT07224256) for real-time speech restoration. As of 28 January 2026, Neuralink reported 21 participants enrolled across its clinical studies.
- PRIME (
NCT06429735) is the foundational early feasibility trial testing N1/R1 safety and wireless computer cursor control in people with quadriplegia. - CONVOY (launched Nov 2024) allows eligible PRIME participants to test neural control of an investigational Assistive Robotic Arm (ARA) and physical mobility interfaces.
- VOICE (
NCT07224256) is a dedicated early feasibility trial decoding speech-motor cortex activity to restore rapid text and personalized voice communication. - All three studies operate under regulatory Investigational Device Exemptions (IDEs) in the U.S. and international partner centers (Canada, UK, UAE)—none is an FDA marketing approval.
Why Neuralink runs separate protocols for cursor, robotic arm, and speech
In medical device regulation, an Investigational Device Exemption (IDE) trial evaluates a specific device configuration, anatomical placement, and clinical endpoint in a defined patient population. Controlling a computer cursor from hand-motor cortex, driving a multi-axis physical robotic arm near a user's face, and decoding speech phonemes from ventral speech-motor cortex involve different risk profiles and functional metrics. Neuralink therefore structures its human clinical program across three complementary trials.
| Program | Registry / launch | Target population & cortical region | Primary safety & feasibility focus |
|---|---|---|---|
| PRIME Study | NCT06429735 · IDE cleared May 2023; 1st implant Jan 2024 | Adults with quadriplegia (cervical SCI or ALS) · Primary motor cortex (hand/arm area) | Surgical/device safety of N1 + R1 and independent home computer/phone control (Telepathy). |
| CONVOY Study | Launched Nov 2024 (cross-enrolled with PRIME) | Participants with severe upper-limb paralysis · Motor cortex multi-DOF decoding | Safety and feasibility of controlling an external Assistive Robotic Arm (ARA) and physical aids. |
| VOICE Study | NCT07224256 · Active 2025–2026 | Adults with severe speech impairment / dysarthria (e.g., ALS, stroke) · Speech motor cortex | Real-time neural decoding of intended speech into text and personalized natural voice output. |
| Patient Registry | neuralink.com/trials · Open in US, Canada, UK & global | Prospective volunteers with paralysis, ALS, speech loss, or blindness | Pre-screening intake database matching prospective volunteers to active study sites. |
Inside the PRIME Study (NCT06429735): the foundational human cohort
PRIME stands for Precise Robotically Implanted Brain–Computer Interface. According to the official PRIME Study Brochure (nl_prime_pdf) and ClinicalTrials.gov record (ct_prime), the trial evaluates both the N1 implant and the R1 surgical robot. Clinical sites include Barrow Neurological Institute in Phoenix, University of Miami, University Health Network (UHN) Toronto Western Hospital in Canada, and University College London Hospitals / Newcastle in the UK.
Official November 2025 overview ('An Introduction to the Neuralink Clinical Trials') explaining how participants join and participate in PRIME, CONVOY, and VOICE.
What the '21 participants' disclosure on 28 January 2026 means
In its official milestone post 'Two Years of Telepathy' published on 28 January 2026 (nl_two_years), Neuralink disclosed that 21 participants ('Neuralnauts') had received implants across its clinical studies—up from 1 participant in January 2024 and 7 participants at the June 2025 Summer Update (FASMejN_5gs). In June 2026, UHN Toronto Western Hospital also completed the first clinical transdural insertion (F8p2MamNBgE).
How prospective patients and families can verify official trial information
If you or a loved one are researching clinical trial eligibility, follow our step-by-step tutorial How to check Neuralink clinical trials and the Patient Registry. Legitimate clinical trials never charge enrollment fees over social media or promote crypto tokens to prospective patients.
Sources checked 30 Oct 2026
Sources and official records
- [1] Neuralink: Clinical Trials and Patient Registry ↗ · Verified 30 Oct 2026
- [2] Neuralink: PRIME Study Brochure (PDF) ↗ · Verified 30 Oct 2026
- [3] Neuralink: Two Years of Telepathy (28 Jan 2026) ↗ · Verified 30 Oct 2026
- [4] Neuralink: CONVOY Study Launch (assistive robotic arm control) ↗ · Verified 30 Oct 2026
- [5] Neuralink: Speech Restoration (VOICE study overview) ↗ · Verified 30 Oct 2026
- [6] ClinicalTrials.gov: The PRIME Study (NCT06429735) ↗ · Verified 30 Oct 2026
- [7] ClinicalTrials.gov: The VOICE Study for Communication Restoration (NCT07224256) ↗ · Verified 30 Oct 2026
- [8] Barrow Neurological Institute: PRIME Study Clinical Trial Information ↗ · Verified 30 Oct 2026
- [9] Neuralink YouTube (2026-04-16): From Neural Signals To Life-Changing Impact | Neuralink ↗ · Verified 30 Oct 2026