Neuralink, the brain-chip company founded by Elon Musk, intends to recruit three participants for an evaluation of its device as per information available on the U.S. government’s clinical trials database. This study is anticipated to span several years for completion.
Initially, Neuralink planned to include ten patients in this trial, as reported by Reuters last year. The brain implant is designed to help people with spinal cord injuries manipulate computers and other devices just by thinking, which could drastically improve their quality of life.
Previously, Neuralink faced criticism for not sharing enough information about its research with the public, which is generally expected in the scientific community. Experts in brain implants and former regulatory officials have urged the company to be more open about its work, as sharing details can build public trust and honor the contributions of participants.
The U.S. Food and Drug Administration (FDA), which has approved this study, supports the idea that companies should make information about their research public. However, the FDA declined to comment specifically on Neuralink’s situation, and company leaders have not responded to requests for more information.
The research is scheduled to complete its first phase in 2026 and conclude entirely in 2031. It is open to individuals aged 22 to 75 suffering from quadriplegia due to spinal injuries or amyotrophic lateral sclerosis (ALS). Candidates must exhibit significant mobility limitations persisting for over a year and have a life expectancy of at least 12 months.
This “first-in-human early feasibility study” began in January, as noted in the registry. Such early studies do not always need to be listed in the U.S. National Institutes of Health’s ClinicalTrials.gov, although major medical journals usually require such registration.
The implant is placed into the brain by a robotic surgical system, targeting areas that control movement intentions. Neuralink’s first patient, Noland Arbaugh, who became paralyzed from the shoulders down after a diving accident in 2016, had the device implanted in January. Since then, he has been able to play video games, surf the web, and move a cursor on his laptop simply by thinking, showcasing the potential of this technology.
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Featured Image courtesy of Gabby Jones/Bloomberg