June 16, 2024

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Neuralink implanted its brain chip on its first patient in January.
Image: Dado Ruvic (Reuters)

Elon Musk’s brain chip startup Neuralink submitted details to a government database about an ongoing study that is testing its brain-computer interface (BCI) device in humans — despite the fact that it wasn’t required to.

Neuralink registered its Precise robotically implanted brain-computer interface (PRIME) study as a “first-in-human early feasibility study” with the U.S. National Institutes of Health’s (NIH) website, ClinicalTrials.gov. Neuralink is currently testing its BCI, which aims to help people with severe quadriplegia control outside technology using their thoughts.

According to details of the study posted to ClinicalTrials.gov on Monday, the study, which is designed to evaluate functionality of the Neuralink’s brain implant and the robot used to implant the device, began in January of this year and is expected to run until 2031 with an estimated three patients. The study will monitor device and procedure-related adverse events up to 72 months after the device is implanted.

Clinical trials in the United States are required to post details on the NIH website. Since the Neuralink’s study was approved by the U.S. Food and Drug Administration as an early feasibility study, however, it is exempted from this rule.

Early feasibility studies are not standard clinical trials that are designed to test a drug or medical devices’s safety and efficacy. Instead, they help companies develop their product’s concept and provide initial safety data. Some major medical journals, however, require such studies to be registered anyway.

The FDA last week gave Neuralink the official go-ahead to implant its experimental brain chip on a second patient.

The approval came after Neuralink said that some threads, which are used to record neural activity, retracted from the brain of the company’s first patient.

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