According to information on the U.S. government’s clinical trials database, Neuralink, Elon Musk’s brain-chip startup, plans to enroll three patients to evaluate its gadget in a study that should take several years to complete.
According to Reuters last year, the company appealed to U.S. regulators to start clinical studies with the goal of enrolling ten patients. Neuralink is testing an implant that could aid people with spinal cord injuries by enabling paralyzed patients to operate digital gadgets simply by thinking.
Brain implant academics and former regulatory officials criticized Neuralink this week for withholding information regarding its experiment, as is customary in the field, prior to the business disclosing the details.
The clinical experiment was approved by the US Food and Drug Administration, which stated that in order to uphold patient dignity and foster public trust, it is usually preferred that firms release information about their research.
Executives from the company did not reply to a request for comment, and the FDA declined to comment on Neuralink.
Neuralink’s study is anticipated to be finished in its whole in 2031, with a priority completion target of 2026. Patients with illnesses like quadriplegia between the ages of 22 and 75 will be recruited for the study.
Patients must meet the qualifying requirements listed in the database, which include having limited mobility without improvement for a minimum of one year and a life expectancy of at least twelve months.
Patients must be able to move their hands, wrists, and arms very little or not at all as a result of a spinal cord injury or the neurological condition known as amyotrophic lateral sclerosis (ALS).
The registration information released on Monday state that the “first-in-human early feasibility study” commenced in January.
The U.S. National Institutes of Health’s ClinicalTrials.gov website does not require early feasibility studies to submit trial details, although prominent medical publications frequently demand trials to be registered on the database.
Long before the business was given the go-ahead last year to start conducting human studies, Neuralink was receiving calls from patients who were interested in participating, according to Neuralink sources.
According to Neuralink, the study used a robot to surgically implant a brain-computer interface (BCI) device in a part of the brain that regulates movement intention.
Neuralink placed the gadget in the brain of Noland Arbaugh, its first patient, in January. Arbaugh had a diving accident in 2016 that left him paralyzed from the shoulders down.
According to corporate blog articles and videos, Arbaugh can now play video games, browse the internet, and operate the laptop’s cursor with just his thoughts.
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