Neuralink, the brain-chip company founded by Elon Musk, plans to enrol three patients in a study to evaluate its device, as per a Reuters report. The study, listed on the United States government's clinical trials database, is expected to take several years to complete.
Originally, the company aimed to enrol 10 patients when it applied to US regulators to begin clinical trials, as reported by Reuters last year. Neuralink's implant is designed to help paralysed patients use digital devices through thought alone, potentially aiding those with spinal cord injuries.
Neuralink has received interest from potential patients for years, even before gaining approval to start human trials last year, Reuters reported, citing sources.
The study involves using a robot to surgically place a brain-computer interface (BCI) implant in the brain region that controls movement intention, as per a company statement.
Neuralink's study is expected to have a primary completion date in 2026, with the full study ending in 2031. The study will involve patients aged 22 to 75 with conditions like quadriplegia.
Eligibility criteria require patients to have had limited mobility for at least one year and a life expectancy of at least 12 months. They must also have very limited or no movement in their hands, wrists, and arms due to spinal cord injuries or amyotrophic lateral sclerosis (ALS).
The “first-in-human early feasibility study” began in January, according to registry details posted on Monday.
Although early feasibility studies are not required to post trial details on the US National Institutes of Health's ClinicalTrials.gov website, major medical journals often require such registration.
In January, Neuralink implanted the device in Noland Arbaugh, a patient paralysed from the shoulders down due to a 2016 diving accident. According to company blog posts and videos, the device has enabled Arbaugh to play video games, browse the internet, and move a computer cursor on his laptop using only his thoughts.
Before Neuralink posted details of its trial, the company faced criticism from brain implant researchers and former regulatory officials for not sharing study information, a common industry practice.
The US Food and Drug Administration (FDA), approved the trial and generally encourages companies to publish study information to build public trust and honour participating patients.
The FDA declined to comment on Neuralink, and the company did not respond to requests for comment.
(With inputs from Reuters)
