According to the information on the clinical trials database maintained by the U.S. government, Neuralink, the brain-chip firm owned by Elon Musk, intends to recruit three patients to test its device in a project anticipated to take a few years to complete.
According to a Reuters report last year, the company had intended to recruit ten patients when it submitted its application to establish clinical trials in the country. The goal of Neuralink’s implant is to provide patients who are paralyzed with the capacity to utilize digital devices solely through their thoughts. This could be beneficial to individuals who have sustained spinal cord injuries.
Neuralink was subjected to scrutiny from brain implant experts and former regulatory officials prior to the firm’s decision to disclose data from its trial this week. The brunt of the criticism was for Neuralink’s failure to engage in the industry-standard practice of releasing details regarding the study.
The U.S. Food and Drug Administration (FDA), which gave its approval to the clinical experiment, said that it is typically preferable for companies to share information about their research to increase public confidence and honor those who take part in the trials.
The FDA did not provide a statement on Neuralink, and officials from the firm did not reply to a request for comments.
The main completion date for the research being conducted by Neuralink is anticipated to be 2026, while the overall study is expected to be finished in 2031. Patients between the ages of 22 and 75 who have conditions such as quadriplegia will be recruited for the research.
Patients must have restricted mobility that has not improved for at least one year, and their life expectancy must be at least 12 months to meet the qualifying requirements displayed on the database pertaining to the program.
To be eligible, patients must have extremely limited or no mobility in their hands, arms, and wrists as a result of spinal cord injury or a neurological illness called amyotrophic lateral sclerosis (ALS).
According to the registration data provided, the “first-in-human early feasibility study” started in January. Noland Arbaugh, who suffered paralysis from the shoulders down in a diving mishap in 2016, became the first patient to have the device implanted in January by the company. Arbaugh has been using the device to play video games, surf the internet, and control his laptop cursor just through his thoughts, as per the company.
Posting trial materials to the U.S. National Institutes of Health’s ClinicalTrials.gov site is not required for early feasibility studies; however, registration on the database is generally required by prominent medical publications.
According to those within Neuralink, the company has been taking patient inquiries over the phone for a long time, even before it got the green light to start human trials last year.
Using a robot, a brain-computer interface (BCI) will be surgically implanted in an area of the brain associated with motor intention, Neuralink has stated.
