PRIME Study Registry and Sponsor Evidence Record

PRIME Study Registry and Sponsor Evidence Record

The current ClinicalTrials.gov record for NCT06429735 identifies PRIME as a recruiting, first-in-human, interventional early feasibility study sponsored by Neuralink Corp.

The registry lists an actual study start of January 9, 2024, an estimated primary completion in June 2026, an estimated study completion in January 2031, and estimated enrollment of 15 participants. It identifies the N1 Implant and R1 Robot as the study devices. The official title concerns control of external devices.

The record showed no posted results when checked on July 28, 2026. An estimated primary-completion date does not mean analysis is complete or results are available. Recruiting status, enrollment, dates, locations, outcomes, and results require a new registry check before publication.

FDA's implanted BCI guidance provides nonclinical and clinical considerations for IDE feasibility and pivotal studies. It does not determine the outcome of PRIME.

Neuralink's first-participant update and second-participant update are sponsor reports. They describe participant experience and technical observations, including thread retraction in the first participant and mitigation claims for the second. Neuralink states that it does not guarantee benefit from participation.

The public research profile should separate registry facts, regulator guidance, sponsor reports, participant statements, and posted results. Absence of posted results is neither positive nor negative evidence.