Patcay.com – Neuralink, the brain-chip company founded by Elon Musk, is initiating a pioneering study by recruiting three patients to test its innovative brain implant device. Detailed on the U.S. government’s clinical trials database, this study is anticipated to take several years to complete.
Originally, Neuralink had sought approval to enroll 10 patients in its clinical trials, as reported by Reuters last year. The brain implant is designed to allow paralyzed patients to control digital devices using their thoughts, potentially benefiting individuals with spinal cord injuries.
Neuralink has faced criticism from brain implant researchers and former regulatory officials for not initially sharing information about the study, a standard practice in the industry.
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The U.S. Food and Drug Administration (FDA), which approved the trial, generally promotes transparency in publishing study information to build public trust and recognize the contributions of participating patients. Despite this, the FDA declined to comment on Neuralink specifically, and company executives did not respond to requests for comment.
The study is projected to reach primary completion by 2026, with full completion expected by 2031. It will involve patients aged 22 to 75 with conditions such as quadriplegia.
Eligibility criteria require patients to have had limited mobility without improvement for at least one year and a life expectancy of at least 12 months. Candidates must have very limited or no movement in their hands, wrists, and arms due to spinal cord injury or amyotrophic lateral sclerosis (ALS).
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The “first-in-human early feasibility study” began in January and was registered on the database on Monday. Although early feasibility studies are generally exempt from posting details on the U.S. National Institutes of Health’s ClinicalTrials.gov website, major medical journals often require trial registration.
Neuralink has reportedly been receiving inquiries from interested patients for several years, even prior to obtaining approval last year to begin human trials.