Neuralink

The Link (previously called N1 sensor or Link 0.9) is a BCI device that is implanted into the brain to allow the user to control a computer or mobile device. The Link is connected to micron-scale threads inserted into areas of the brain to control movement. The Link transmits neural signals received from the neural threads, which contain electrodes to detect neural signals. The device uses an inductive charger that wirelessly connects to the implant to charge the battery. The shape of the Neurolink BCI device changed to be coin-shaped and fit flush with the skull, rather than the previous design resting near the ear. Musk stated that the device matches the thickness of the piece of skull that had been removed to insert it. Musk stated on X on January 29, 2024 that, that Neuralink's first product is called Telepathy.

The PRIME Study (Precise Robotically Implanted Brain-Computer Interface) is an investigational medical device clinical trial for Neuralink’s fully-implantablefully implantable, wireless BCI that aims to evaluate the safety of the implant (N1) and surgical robot (R1), and the functionality of the BCI for enabling people with quadriplegia to control external devices with their thoughts. A small implant is placed in the part of the brain that controls movements whichand interprets neural activity. The device is designed to allow the person to operate a computer or smartphone by intending to move, without the requirement of physical movement. According to Neuralink, people who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.

The PRIME study received U.S. FDA clearance in May 2023 and began recruiting patients in September 2023. On January 28, 2024, the first person enrolled in the trial recievedreceived an implant. Participants in the PRIME Study will have nine visits with researchers in an 18-montheighteen-month period. They will then spend at least two hours a week on brain-computer interface research sessions and have 20twenty more research visits over the next five years.

The FDA classifies The Link as a Class III device. In early 2022, the FDA rejected Neuralink’s application for the device to be used in clinical trials. Some of the safety concerns raised by the FDA include the lithium battery;, potential migration of tiny wires to other areas of the brain;, and uncertainty over the ability to remove the device without damaging brain tissue. Neuralink launched a patient registry in late 2022 to learn more about individuals who may be interested in enrolling in future Neuralink clinical trials.

Stated plans for the first clinical study for the N1 sensor/Link focused on patients with quadriplegia due to C1-C4C1–C4 spinal cord injury and will use a four-chip setup to enable patients to control their smartphones using their brains. One of the N1 sensors would be implanted in the somatosensory cortex, and the other three would be placed in the motor cortex. Each sensor has more than a thousand electrodes. Through that, they will be able to control a computer mouse and keyboard by using a Bluetooth connection. Musk stated in 2017 that it may be around eight to ten years before the device is available for people without disabilities.

The company claims that version one of their Neural Lace, called the N1 Sensor, is made of 1024-channel sensors on a 4mm by 4mm computer chip, and that it's is possible to scale their chip to contain up to 10,000-channel sensors in later versions. The N1 chip is made to communicate with other devices wirelessly and is capable of reading and writing information. The N1 Sensor will be controllable through a mobile application, a Bluetooth mouse, and a Bluetooth keyboard forto helpinghelp patients learn how to use the chip effectively after implantation while they are at home.

The Link (previously called N1 sensor or Link 0.9) is a BCI device that is implanted into the brain to allow the user to control a computer or mobile device. The Link is connected to micron-scale threads inserted into areas of the brain to control movement. The Link transmits neural signals received from the neural threads, which contain electrodes to detect neural signals. The device uses an inductive charger that wirelessly connects to the implant to charge the battery. The shape of the Neurolink BCI device changed to be coin-shaped and fit flush with the skull, rather than the previous design resting near the ear. Musk stated that the device matches the thickness of the piece of skull that had been removed to insert it. Musk stated on X on January 29, 2024 that that Neuralink's first product is called TelapathyTelepathy.

The PRIME Study (Precise Robotically Implanted Brain-Computer Interface) is an investigational medical device clinical trial for Neuralink’s fully-implantable, wireless BCI that aims to evaluate the safety of the implant (N1) and surgical robot (R1), and the functionality of the BCI for enabling people with quadriplegia to control external devices with their thoughts. A small implant is placed in the part of the brain that controls movements which interprets neural activity. The device is designed to allow the person to operate a computer or smartphone by intending to move, without the requirement of physical movement. According to Neuralink, people who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify. The PRIME study received U.S. FDA clearance in May 2023 and began recruiting patients in September 2023. On January 28, 2024, the first person enrolled in the trial recieved an implant.

The PRIME study received U.S. FDA clearance in May 2023 and began recruiting patients in September 2023. On January 28, 2024, the first person enrolled in the trial recieved an implant. Participants in the PRIME Study will have nine visits with researchers in an 18-month period. They will then spend at least two hours a week on brain-computer interface research sessions and have 20 more research visits over the next five years.

The Link (previously called N1 sensor or Link 0.9) is a BCI device that is implanted into the brain to allow the user to control a computer or mobile device. The Link is connected to micron-scale threads inserted into areas of the brain to control movement. The Link transmits neural signals received from the neural threads, which contain electrodes to detect neural signals. The device uses an inductive charger that wirelessly connects to the implant to charge the battery. The shape of the Neurolink BCI device changed to be coin-shaped and fit flush with the skull, rather than the previous design resting near the ear. Musk stated that the device matches the thickness of the piece of skull that had been removed to insert it. Musk stated on X on January 29, 2024 that that Neuralink's first product is called Telapathy.

The PRIME Study (Precise Robotically Implanted Brain-Computer Interface) is an investigational medical device clinical trial for Neuralink’s fully-implantable, wireless BCI that aims to evaluate the safety of the implant (N1) and surgical robot (R1), and the functionality of the BCI for enabling people with quadriplegia to control external devices with their thoughts. A small implant is placed in the part of the brain that controls movements which interprets neural activity. The device is designed to allow the person to operate a computer or smartphone by intending to move, without the requirement of physical movement. According to Neuralink, people who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify. The PRIME study received U.S. FDA clearance in May 2023 and began recruiting patients in September 2023. On January 28, 2024, the first person enrolled in the trial recieved an implant.

Neuralink is a company that develops brain-computer interface (BCI) devices to assist people with paralysis and blindness and technologies that may expand the abilities of humans. The San Francisco, California-based company was founded in 2016 by Elon Musk and Max Hodak. The BCIs in development by Neuralink are designed to be high bandwidthhigh-bandwidth brain-machine interfaces that connect people and machines in productive ways. The company aims to solve brain diseases in the short term and have a fully functional machine-human interface in the long term. The initial goal of Neuralink has been for its implants “to give people with paralysis their digital freedom back” by letting them “communicate more easily via text, to follow their curiosity on the web, to express their creativity through photography and art, and, yes, to play video games.”

Neuralink released a white paper in 2019 that describes their BCI/BMI system. In 2020, Neuralink showcased a pig named Gertrude implanted with their BCI device that records signals from an area of the brain that receives touch information from her snout. In a livestream “show and tell” event in November 2022, Elon Musk stated that one of the applications of Neuralink BCI technology would be the restoration of vision to people with blindness and showed that a Neuralink implant stimulated a visual sensation in a monkey’s brain. A challenge acknowledged by Neuralink in 2019 is to achieve longevity of the devices and to prevent potential safety issues due to the device breakdown in the harsh environment inside the brain.Therebrain. There are no peer-reviewed academic publications by Neuralink on PubMed as of April 2023.

Neuralink’s 2019 non-peer reviewed whitepaper demonstrates two of their devices, System A and System B, were implanted in rats and took electrophysiological recordings as they moved around freely. Digitized broadband signals were processed in real time to identify action potentials, also referred to as spikes, using an online detection algorithm. Neuralink uses custom spike-detection software to filter out false positive spikes. Their threshold was set to >0.35 Hz to quantify the number of electrodes recording spiking units. The simultaneous recording from over 3000 inserted electrodes in a freely moving rat was reported. The placement of electrodes was successful 87% of the time in nineteen rats. Neuralink did not demonstrate capabilities for modulating neural activity but states that their device is designed to be capable of electrical stimulation on every channel.

Neuralink’s devices build upon academic research in deep brain stimulation, cochlear implants, neurostimulation for epilepsy, and the Utah array. The Utah array, used for neural recording in BCI research and the BrainGate device, is made of a rigid grid of up to 128 electrode channels. In comparison, Neuralink states its systems can record from 1,500 or 3000 electrode channels. The thin, flexible electrodes are claimed to be less likely to cause tissue damage than the Utah Array, which is known to cause a tissue response that can interfere with recorded signals or damage brain cells. Elon Musk prefers to use the term "neural lace" for the BCIs in development by Neuralink. He took the term from a series of science fiction books written by the Scottish novelist Iain M. Banks called The Culture.

The company is making a neural lace with the ability to recognize and interact with the electrical and chemical signals passing through the nervous system within neurons. Their devices in development detect the electrical field produced by nerve action potentials and record the information represented by a neuron. The brain is then represented by the firing statistics of action potentials. Neural recordings can be decoded and turned into electrical signals fed back to the nervous system or into robotic devices. Neuralink's N1 Sensor is designed to "record from and selectively stimulate as many neurons as possible across diverse brain areas." The company has three publicly stated goals for its neural lace technology:

The goal is for the procedure to take place under conscious sedation and local anesthetic. Each N1 Sensor will be placed into a patient's brain by a surgical robot. The robot will make a 2mm incision that dilates to approximately 8mm before the chip is implanted into the brain. The robot will place each thread (approximately 1/3 the size of a human hair) coming off of their N1 Sensor computer chip to their desired locations (determined by a neurosurgeon) within the brain. Threads are about the diameter of a neuron. The sensor will be placed to fill the hole in the skull, and the scalp will be closed over it. The procedure will produce an incision that can be glued shut and does not require stitches. Each chip placed within a patient's brain will have a power wire running under the patient's scalp to an inductive coil found behind the patient's ear. The inductive coil will be connected to a wearable device called "The Link," which acts as the power supply and Bluetooth radio. If The Link is removed, the implant will shut off and stop working.

The company claims that version one of their Neural Lace, called the N1 Sensor, is made of 1024-channel sensors on a 4mm by 4mm computer chip, and that it's possible to scale their chip to contain up to 10,000-channel sensors in later versions. The N1 chip is made to communicate with other devices wirelessly and is capable of reading and writing information. The N1 Sensor will be controllable through a mobile application, a bluetoothBluetooth mouse, and a bluetoothBluetooth keyboard for helping patients learn how to use the chip effectively after implantation while they are at home.

The surgical robot developed by Neuralink is made to perform the placement of threads coming off the N1 sensor into a patient's brain during surgery. The robot's insertion needle is milled from a 40 micrometer40-micrometer diameter tungsten-rhenium wire stock that is electrochemically etched into a 24 micrometer24-micrometer diameter for the length of the insertion needle that gets inserted into the brain. A diagram of the insertion needle can be found below, along with an image of the insertion needle inserting a thread of the N1 Sensor:

The robot registers insertion sites to a common coordinate frame with landmarks on the skull and also uses depth tracking to target anatomically defined brain structures. Insertion sites are pre-selected for planning optimal paths to minimize tangling and strain on threads and avoid vasculature damage. The robot can insert up to 6six threads per minute. While the system is automated, a surgeon can make manual microadjustmentsmicro-adjustments.

The main substrate and dielectric used in the probes is polyimide encapsulating a thin, gold thin film trace. Each thin film array has a “thread” area with electrode contacts and traces and a “sensor area” where the film interfaces with custom chips enabling signal amplification and acquisition. The devices can be manufactured in a high-throughput manner using a wafer-level microfabrication process. On a wafer, ten thin film devices are patterned, each with 3,072 contacts. Each array has 48forty-eight or 96ninety-six threads, with each containing 32thirty-two independent electrodes. A flip-chip bonding process is used to bond integrated chips to the contacts on the sensor area of the thin film.

To keep the channel count high with a minimal sizeminimal-size thread to minimize tissue displacement in the brain, stepper lithography and other microfabrication techniques are used. A metal film at sub-micron resolution is produced. Threads are reported to be normally 4 to 6 micrometers thick, including up to three layers of insulation and two layers of conductor and are 20 mm long. Surface modifications are used to lower impedance for electrophysiology and increase the effective charge-carrying capacity of the interface. Treatments include polymer poly-ethylenedioxythiophene doped with polystyrene sulfonate (PEDOT:PSS) and iridium oxide (IrOx).

The custom Neuralink application specific integrated circuit (ASIC) is used to build the electronics component, which consists of 256 individually programmable amplifiers (“analog pixels”), on-chip analog-to-digital converters (ADCs), and peripheral control circuitry for serializing the digitized outputs. The Neuralink ASIC forms the core of a modular platform. Neuralink uses a number of ASICs integrated into a standard printed circuit board using flilp-chipflip-chip integration. The systems are packaged in titanium cases coated in parylene-c as a moisture barrier. Neural data from these systems are streamed from an ethernet-connected base station. Each station can connect up to three implants simultaneously.

Neuralink released a white paper in 2019 that describes their BCI/BMI system. In 2020, Neuralink showcased a pig named Gertrude implanted with their BCI device that records signals from an area of the brain that receives touch information from her snout. In a livestream “show and tell” event in November 2022, Elon Musk stated that one of the applications of Neuralink BCI technology would be the restoration of vision to people with blindness and showed that a Neuralink implant stimulated a visual sensation in a monkey’s brain. A challenge acknowledged by Neuralink in 2019 is to achieve longevity of the devices and to prevent potential safety issues due to the device breakdown in the harsh environment inside the brain.There are no peer-reviewed academic publications by Neuralink on PubMed as of April 2023.

Neuralink’s 2019 non-peer reviewed whitepaper demonstrates two of their devices, System A and System B, were implanted in rats and took electrophysiological recordings as they moved around freely. Digitized broadband signals were processed in real time to identify action potentials, also referred to as spikes, using an online detection algorithm. Neuralink uses custom spike-detection software forto filter out false positive spikes. Their threshold was set to >0.35 Hz to quantify the number of electrodes recording spiking units. The simultaneous recording from over 3000 inserted electrodes in a freely moving rat was reported. The placement of electrodes was successful 87% of the time in 19nineteen rats. Neuralink did not demonstrate capabilities for modulating neural activity, but statestates that their device is designed to be capable of electrical stimulation on every channel.

Joseph E. O’Doherty, neuroengineer at Neuralink, is one of the first co-authors on a paper published in BioRxiv in April 2019 with his previous team of researchers in Brazil, Russia, and at Duke University. The paper described monkeys using brain-machine-brain interface that learned to interpret intracortical microstimulation of the primary somatosensory cortex (S1) and propose the potential to encorporateincorporate their approach into upper-limb neuroprostheses.

Supin Chen and Vanessa M. Tolosa of Neuralink are authors onof a Journal of Neural EngineeringJournal of Neural Engineering paper describing the design and fabrication of silicon insertion shuttles for faster, easier, and less damaging implantation of polymer arrays into the brain.

In August 2020, Musk revealed a "three little pigs demo," in which a pig named Gertrude had been implanted with a Neuralink implant. Musk stated the company, using implant data, predicted a pig’s limb movement at a "high accuracy" during a treadmill run at “high accuracy” using implant data.

In April 2021, Neuralink demonstrated that a monkey named Pager with a brain implant device called "Link" was able to play the game Pong, without using a joystick and only its brain.