By Katabella Roberts
Elon Musk’s neurotechnology company Neuralink has received approval from an independent review board and hospital to begin recruiting for the first ever human trials of its brain implant for paralysis patients.
In a press release, Neuralink said it has begun recruiting patients with quadriplegia owing to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) for the clinical trial.
The trial, known as the Precise Robotically Implanted Brain-Computer Interface study, or PRIME study, will use a robot to surgically place a wireless brain-computer interface (BCI) implant in a region of the brain that controls movement intention.
Once in place, the implant is “cosmetically invisible” and will “record and transmit brain signals wirelessly to an app that decodes movement intention,” Neuralink said.
San Francisco-based Neuralink, which was co-founded by Musk in 2016, aims to build “the first neural implant that will let you control a computer or mobile device anywhere you go,” according to its website.
The upcoming trial, which is expected to take roughly six years to complete, will test the safety and initial effectiveness of the implant that will allow participants to control a computer cursor or keyboard using just their thoughts.
Neuralink’s study in humans is being conducted under the investigational device exemption (IDE) after it was granted approval from the Food and Drug Administration in May.
The company began testing brain implants in animals back in 2019, and in 2020 successfully implanted artificial intelligence microchips in the brain of a pig named Gertie.
Concerns Over Animal Research
In April 2021, the startup published a video showing Pager, a 9-year-old macaque, playing computer games through a neural implant that was inserted into the monkey’s brain.
However, the company has also raised concerns over its animal research.
In February this year, the U.S. Department of Transportation announced it was investigating the company over allegations of potential illegal movement of hazardous pathogens.
According to the department, Neuralink may have transported potentially dangerous pathogens when removing the chips from monkeys’ brains without implementing proper measures to contain them.
The implants may have carried infectious diseases in violation of federal law.
Separately, Reuters reported that Neuralink is under investigation by the U.S. Department of Agriculture’s Office of Inspector General over potential violations of the Animal Welfare Act.
Mr. Musk has previously said that monkeys used by the company in animal trials enjoy doing the tasks and are happy and that Neuralink “cares about animal welfare” amid concerns from animal rights groups.
According to a Neuralink brochure (pdf), the human trial will consist of a primary study, BCI research sessions, and a long-term follow-up. Participants will have nine at-home and in-person clinic visits for the first 18 months and will be asked to take part in the research sessions twice a week for one hour for the duration of the study. They will also need to complete 20 long-term follow-ups over five years.
Trial Eligibility
To be eligible for the study, participants must be at least 22 years of age, have quadriplegia owing to spinal cord injury or ALS, and be at least one year post-injury “without improvement.”
They must also have a “consistent and reliable caregiver,” according to the company.
Neuralink said Tuesday that the study “represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.”
Mr. Musk’s startup is one of many testing implants to help people with paralysis.
In August, researchers at the University of California, San Francisco, and the University of California, Berkeley revealed that a woman who was left severely paralyzed after suffering a stroke was able to communicate again thanks to a brain-computer interface which translates brain signals into modulated speech and facial expressions via AI.
Elsewhere, a paralyzed man was able to walk again for the first time in years thanks to an implant fitted in his brain and spinal cord by an international team of researchers, led by Dr. Grégoire Courtine, Professor Jocelyne Bloch, and others from the Swiss Federal Institute of Technology in Lausanne.
The implant allowed the man to voluntarily move his legs and feet just by thinking about it.
Neuralink was valued at $5 billion in June.
Mimi Nguyen Ly and Reuters contributed to this report.
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