Elon Musk's brain-chip implant company has begun recruiting for its landmark first-in-human trial. "We are pleased to announce that we have received approval from the independent institutional review board and first hospital to begin recruiting for our first-in-human clinical trial," Neuralink said in a statement.
The PRIME study (short for Precise Robotically Implanted Brain-Computer Interface) is a groundbreaking medical device trial of a fully implantable wireless brain-computer interface (BCI) designed to evaluate the safety of the implant (N1) and surgical robot (R1) and evaluate the preliminary functionality of our BCI in helping paralyzed patients control external devices with their thoughts.
"The R1 robot will be used to surgically implant the N1 implant's ultra-fine, flexible threads into the area of the brain that controls movement intention," the statement continued. "Once implanted, the N1 implant is visually invisible and is designed to record brain signals and transmit them wirelessly to an application that decodes motor intentions. Our initial goal with the BCI is to enable people to control a computer cursor or keyboard with just their thoughts."
Unsurprisingly, first-in-human trials have strict criteria for possible selections. Participants must have quadriplegia (limited function of the limbs) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) and be at least one year post-injury (without improvement). They must be over 22 years old and have a caregiver. However, anyone in this group who is also prone to seizures, has an active implant such as a pacemaker, or requires ongoing MRI or similar treatment will be excluded.
The company also invites anyone to join its patient registry, with more trials expected to follow.
The study is expected to last six years and will be continuously monitored. The first phase is a primary study, which will include nine home and outpatient consultations over 18 months. Afterwards, patients must undergo 20 consultations over five years.
BCI research sessions will then run throughout the trial and will take place twice a week for one hour each.
In May this year, the U.S. Food and Drug Administration (FDA) gave Neuralink the green light to conduct human trials. Compared with two months ago, Neuralink’s attitude has changed rapidly. Two months ago, the U.S. Food and Drug Administration reportedly refused to approve the trial, citing safety concerns. (The agency declined to comment at the time).
On May 25, Neuralink wrote on Twitter: "We are excited to report that we have received FDA approval to conduct a first-in-human clinical study! This is the result of the Neuralink team's close collaboration with the FDA and an important first step in how our technology will one day help more people. [PRIME study] represents an important step in our mission to create a universal brain interface to restore autonomy to those with unmet medical needs. Neuralink
Neuralink was founded by Musk in 2016 with the goal of developing a brain-chip interface that, when implanted in the skull, could successfully allow people with various disabilities to restore movement, communication, and possibly vision.
However, it quickly sparked controversy. In February 2022, the company faced accusations of mismanagement of monkey deaths at its initial testing laboratory at the University of California, Davis. Both Neuralink and the University of Davis issued statements confirming that caution is being taken with all live specimens.
"To collect important histology data, two animals were euthanized at the planned end date and six animals were euthanized at the medical advice of UC Davis veterinary staff. These reasons included one surgical complication from the use of an FDA-approved product (BioGlue), one device malfunction, and four suspected device-related infections, a risk inherent with any percutaneous medical device. To this end, we developed new surgical protocols and designed a fully implantable device for future surgeries," Neuralink's statement read.
Yet despite this statement, titled "Neuralink's Commitment to Animal Welfare," a shocking December 2022 Reuters report detailing dozens of company documents and interviews with more than 20 current and former employees revealed incidents of excessive, unnecessary animal cruelty and death - 1,500 animals have died since 2018 - many of which were the result of the program's alarming pace.
However, Neuralink was cleared in March after the Department of Agriculture’s Office of the Inspector General launched an investigation into violations of the Animal Welfare Act.
It's unclear how many patients will be admitted to the historic PRIME study.