Neuralink revealed in a statement that they will start human trials of brain implants for paralysis patients.
Neuralink, a neurotechnology startup founded by Elon Musk, has been given the go-ahead to start recruiting patients for the first-ever human trials of its brain implant for paralysis sufferers.
Neuralink revealed in a statement that patient recruitment for the clinical study has started for those with quadriplegia brought on by a cervical spinal cord injury or amyotrophic lateral sclerosis (ALS).
The PRIME research, also known as the Precise Robotically Implanted Brain-Computer Interface study, involves surgically implanting a wireless brain-computer interface (BCI) in a part of the brain that regulates movement intention using a robot.
The implant, once in place, will be “cosmetically invisible” and “record and transmit brain signals wirelessly to an app that decodes movement intention,” according to the business.
Neuralink, a San Francisco-based company that Mr. Musk helped co-found in 2016, seeks to create “the first neural implant that will let you control a computer or mobile device anywhere you go,” according to its website.
The future experiment, which will likely take six years to complete, will evaluate the implant’s initial efficacy and safety before participants may use it to mentally manipulate a computer cursor or keyboard.
Neuralink’s human trial is being carried out under the investigational device exemption (IDE), after the FDA’s clearance of the device in May.
In 2020, the business successfully inserted artificial intelligence microchips into the brain of a pig called Gertie as part of its animal trials for brain implants.
According to Dr. Erick Eiting, vice chair of operations for emergency medicine at Mount Sinai Downtown in New York City, doctors are now struggling to differentiate between COVID-19, allergies, and the common cold.
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Concerns Over Animal Research
The firm released a video in April 2021 that showed Pager, a 9-year-old macaque, using a neural implant in his brain to play video games.
However, there are certain worries related to Neuralink’s animal study as well.
The Department of Transportation said in February that it was looking into the business following claims of possible unlawful pathogen transfer.
Neuralink may have transmitted potentially harmful germs when removing the chips from the animals’ brains without taking the necessary precautions to confine them, claims the department. Federal law may have been broken since the implants may have contained contagious pathogens.
Separately, Reuters reported that Neuralink is the subject of an inquiry by the Office of Inspector General of the Department of Agriculture over possible Animal Welfare Act breaches.
In response to concerns from animal rights organizations, Mr. Musk has previously stated that Neuralink “cares about animal welfare” and that the monkeys employed by the business in animal studies “enjoy doing the tasks” and are happy while doing them.
The human experiment will include a main study, BCI research sessions, and a long-term follow-up, according to a Neuralink brochure (pdf below). For the first 18 months, participants will have nine in-home and in-person clinic appointments. They will also be required to participate in research sessions twice a week for an hour throughout the course of the study. Over the course of five years, they will also need to complete 20 long-term follow-ups.
Trial Eligibility
Participants in the study must be at least 22 years old, suffer quadriplegia as a result of a spinal cord injury or ALS, and have been “without improvement” for at least one year after the accident.
A “consistent and dependable caregiver” is also required, according to the corporate brochure.
According to a statement released by Neuralink on September 19, the study “represents an important step in our mission to create a generalized brain interface to restore autonomy to those with unmet medical needs.”
One of the startups investigating implants to aid those with paralysis is Mr. Musk’s.
A woman who was severely paralyzed after having a stroke was able to communicate again in August, according to researchers at the Universities of California, San Francisco and Berkeley. This was made possible by a brain-computer interface that uses artificial intelligence (AI) to translate brain signals into modulated speech and facial expressions.
An international team of researchers led by Grégoire Courtine, professor Jocelyne Bloch, and others from the Swiss Federal Institute of Technology in Lausanne successfully implanted an implant in a crippled man’s brain and spinal cord, enabling him to walk again for the first time in years.
The man can now actively move his legs and feet by simply thinking about doing so thanks to the implant.
In June, Neuralink was given a $5 billion valuation.