Neuralink To Begin Brain Implant Trial On Paralysed Patients

Neuralink, the Elon Musk-founded start-up aimed at developing wireless brain-machine interfaces, has gained approval to begin human trials.

The firm announced in a blog post it has “received approval from the reviewing independent institutional review board and our first hospital site to begin recruitment for our first-in-human clinical trial.”

In December 2022 Musk had said he hoped human trials would begin within six months, and in March this year Neuralink reportedly approached a major US neurosurgery centre (Barrow Neurological Institute) as a potential partner in human clinical trials, should they be approved by regulators.

Human trial

Neuralink is focused on creating chips that can be implanted in the human brain, with the end goal of enabling people to effectively merge with software and adapt to the advancements in artificial intelligence (AI).

Essentially, the goal is to create brain interfaces to alleviate symptoms of chronic medical and neurological conditions in human beings.

But Musk also wants it to eventually treat conditions such as obesity, autism, depression and schizophrenia.

In its blog post the firm confirmed it had received approval for recruitment for its first-in-human clinical trial, which Neuralink is calling the PRIME Study (Precise Robotically Implanted Brain-Computer Interface).

Neuralink described this as a “groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI).” It said the PRIME study aims to “evaluate the safety of its implant (N1) and surgical robot (R1) and assess the initial functionality of our BCI for enabling people with paralysis to control external devices with their thoughts.”

“During the study, the R1 Robot will be used to surgically place the N1 Implant’s ultra-fine and flexible threads in a region of the brain that controls movement intention,” said Neuralink. “Once in place, the N1 Implant is cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of our BCI is to grant people the ability to control a computer cursor or keyboard using their thoughts alone.”

The PRIME Study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023, the firm added.

Those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify, and those interested can apply here.

Animal testing

Musk had first revealed his plans to develop a human brain to computer interface back in 2017.

Then in July 2020 Musk touted the ability of the brain implant chip to stream music wirelessly into the brain, bypassing earphones or even ears. A month later Musk called the brain implants a “Fitbit for your skull”.

For years Neuralink has been testing its brain interface chip with animals, as it sought approval from the US Food and Drug Administration (FDA) to begin clinical trials in people.

For example in April 2021, Neuralink posted a video that showed a monkey playing a game of Pong using only signals from its mind.

That video showed the monkey first controlling the game using a joystick, and being rewarded with a banana smoothie delivered through a metal straw. Meanwhile the implanted chip records the brain signals used to control the joystick.

When the scientific team disconnected the joystick, the monkey continued to play, but now the game of “MindPong”, as the company nicknamed it, was apparently controlled using brain signals only from the monkey.

Neuralink had also previously showed a video of a pig called Gertrude (Gertie) with an implant that allowed her neural activity to be tracked as she looked for food.

Federal investigation

But the animal testing has not been without controversy.

In February 2022 Neuralink admitted eight monkeys had died during its research, as it responded to a legal complaint from an anti animal testing group.

Then December 2022 it emerged that Neuralink was under federal investigation for potential animal-welfare violations. It came amid alleged internal staff complaints that animal testing at Neuralink was being rushed, causing needless suffering and deaths.

And some have noted that Neuralink has been lagging behind medical device rivals, such as Synchron, which crossed a major milestone in July 2022 by implanting its device in a patient in the United States for the first time.

Synchron had received US regulatory clearance for human trials back in 2021 and had already completed studies in four people in Australia. The company’s device has allowed paralysed people to text and type by thinking alone.

In September Synchron announced the completion of patient enrollment in its US-based COMMAND trial.