Elon Musk’s Neuralink is looking to enroll three people in a long-term study of its brain implant, Reuters reported on Wednesday, referring to the details on U.S. government’s clinical trials database. The trial will assess a device that could enable paralyzed people to control digital devices with their thoughts. Neuralink’s implant is said to greatly benefit patients with spinal cord injuries or ALS.
Neuralink initially planned to start with 10 patients, when it applied to U.S. regulators to begin clinical trials, according to a Reuters report last year.
Talking about the study timeline, it is expected to reach its primary completion by 2026, with the overall study concluding in 2031. In terms of participant criteria, the study will target patients aged 22 to 75 with conditions like quadriplegia. It further mandates the eligible patients to have limited mobility for at least a year and a life expectancy exceeding one year. Eligible participants must also have minimal to no hand, wrist, and arm movement due to spinal cord injury or ALS.
The inaugural phase of the study, labeled the “first-in-human early feasibility study,” reportedly commenced in January. Although early feasibility studies are not mandated to disclose trial details on the U.S. National Institutes of Health’s ClinicalTrials.gov website, major medical journals often require such registration.
However, prior to releasing details this week, the company faced criticism for withholding study information, a standard practice within the field. The U.S. Food and Drug Administration (FDA), which greenlit the trial, typically advocates for companies to disseminate study information to foster public trust and acknowledge the contributions of participating patients.
Meanwhile, after years of research and testing, they began human trials last year, receiving FDA approval in September. And earlier this year, the company announced that its first human patient implanted with a brain-computer interface chip has successfully used it to control a computer mouse with just their thoughts.
