Neuralink Human Trials

Context:

Elon Musk’s neurotechnology company Neuralink has received FDA approval to begin human trials.

Neuralink has had the ambitious mission to build a next-generation brain implant with at least 100 times more brain connections than devices currently approved by the U.S. Food and Drug Administration (FDA).

What is Neuralink?

Neuralink is making a Class III medical device known as a brain-computer interface (BCI).
Size of BCI: The device itself is a coin-sized unit called a Link.
Location in the body: It’s implanted within a small disk-shaped cutout in the skull using a precision surgical robot.
Working process:
- The device connects the brain to an external computer via a Bluetooth signal, enabling continuous communication back and forth.
- The robot splices a thousand tiny threads from the Link to certain neurons in the brain. Each thread is about a quarter the diameter of a human hair.

Potential benefits of Neuralink’s BCI

Enable precise control of prosthetic limbs, giving amputees natural motor skills.
Revolutionise treatment for conditions such as Parkinson’s disease, epilepsy and spinal cord injuries.
Promise for potential treatment of obesity, autism, depression, schizophrenia and tinnitus.
Help older people train their motor and cognitive abilities to moderate the worst effects of ageing.

FDA’s concerns

The FDA had quite a list of issues that needed to be resolved before human trials could commence.

Safe surgery:
- A precision robot known as Implant/r1 performs the surgical procedure to implant the Neuralink BCI.
- This robot surgeon had to be put through its paces to gather evidence that it could reliably and safely implant and remove the Neuralink BCI without damaging surrounding brain tissue, or creating the risk of infection, bleeding, inflammation or scarring.

Harmful side effects:
- Once implanted, the Neuralink BCI must function as intended.
- It must not unintentionally influence other brain functions, or cause any unwanted side effects such as seizures, headaches, mood changes, or cognitive impairment.

Safe power supply:
- In particular, overheating lithium-ion batteries can pose great risk to BCI users.
- They can even explode if the insulation between the cathode and anode (the metal electrode components) breaks down, resulting in a short circuit.
- The longevity of the battery and safely replacing from its position under the skin behind the ear was also a concern.
Risk of wire migration:
- The Link consists of a disk-shaped chip with very thin wire electrodes that connect to neurons in the brain.
- Connecting these wires by means of a surgical robot may possibly move the electrodes elsewhere in the brain over time due to natural movement, inflammation, or scar tissue formation.
- This would likely affect the proper functioning of the device, and could cause infection or damage to the brain tissue.
Data privacy and security: Strong safeguards are required to prevent data collected by the Link from being hacked, manipulated or otherwise misused.