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Elon Musk’s Neuralink is trying to enroll three patients in ET HealthWorld’s brain implant trial

London: Elon Musk’s brain chip company Neuralink intends to enroll three patients to evaluate its device in a study expected to last several years, according to details included in the US government’s clinical trials database.

As Reuters reported last year, the company sought to enroll 10 patients when submitting an application to U.S. regulators to begin clinical trials. Neuralink is testing its implant, which is intended to give paralyzed patients the ability to use digital devices by thinking for themselves, which could help people with spinal cord injuries.

Before Neuralink released details of its study this week, the company faced criticism from brain implant researchers and former regulatory officials for not sharing information about the study, as is common in the industry.

The U.S. Food and Drug Administration, which approved the clinical trial, said it generally prefers that companies publish information about their trials to increase public trust and honor the patients participating in them.

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The FDA declined to comment on Neuralink, and company executives did not respond to a request for comment.

The Neuralink study is estimated to have an initial completion date of 2026, with full completion expected in 2031. The study will enroll patients aged 22 to 75 with conditions such as quadriplegia.

According to the eligibility criteria in the database, patients must have had limited mobility without improvement for at least one year and a life expectancy greater than or equal to 12 months.

Eligible patients must have very limited or no movement of their hands, wrists and arms due to spinal cord injury or a neurological disorder called amyotrophic lateral sclerosis (ALS).

The “first early human feasibility study” began in January, according to registry data released Monday.

Early feasibility studies are exempt from the requirement to post study details on the U.S. National Institutes of Health’s ClinicalTrials.gov website, but major medical journals often require studies to be registered in a database.

Neuralink sources say Neuralink has been fielding calls from interested patients for years, well before it received approval to begin human trials last year.

The study used a robot to surgically place a brain-computer interface (BCI) implant in the area of ​​the brain that controls movement intention, Neuralink said.

In January, Neuralink implanted the device into the brain of its first patient, Noland Arbaugh, who is paralyzed from the shoulders down following a 2016 diving accident.

According to posts and videos on company blogs, the device allowed Arbaugh to play video games, browse the Internet and move the cursor on his laptop while thinking independently.

  • Posted on May 29, 2024 at 12:07 pm EST

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