Neuralink has announced that it has received approval from the reviewing independent institutional review board and its first hospital site to begin recruitment for its first-in-human clinical trial.
The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface) – is billed as “a groundbreaking investigational medical device trial” for Neuralink’s fully-implantable, wireless brain-computer interface (BCI) – aims to evaluate the safety of its implant, called the N1 and surgical robot, called the R1 and assess the initial functionality of its BCI for enabling people with paralysis to control external devices with their thoughts.
During the study, Neuralink says 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. Once in place, we’re told 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, with Nueralink naturally stating this represents an important step in its mission to create a generalised brain interface to restore autonomy to those with unmet medical needs.
Those who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS) may qualify.
If you’re interested in learning whether you may qualify for current and future Neuralink clinical trials, Neuralink invites you to consider joining its Patient Registry.
To learn more, you can download the study brochure here.
From the first page of the brochure:
We invite you to participate in the PRIME Study – a ground- breaking investigational medical device clinical trial for our first brain-computer interface.
If you have quadriplegia and are interested in exploring new ways of controlling your computer, you may qualify.
What are brain-computer interfaces?
Brain-computer interfaces (BCIs) are systems that decode intended movement signals from brain activity to control external devices such as computers.
What is the purpose of this study?
This is a first-in-human study with the purpose of evaluating the safety and initial effectiveness of the N1 Implant (a BCI implant), the R1 Robot (a surgical robot), and N1 User App (BCI software) in enabling individuals with paralysis to control external devices.
The devices used in this study are investigational, and not for sale.
What does the study involve?
During the study, the R1 Robot will be used to surgically place the N1 Implant in a region of the brain that controls movement intention.
Participants will be asked to use the N1 Implant and N1 User App to control a computer and provide feedback about the system.
Compensation
You will be compensated for study-related costs (such as travel expenses to and from the study site).
Our Devices
N1 Implant
Once surgically placed, the N1 Implant is cosmetically invisible. It records and transmits brain activity with the goal of enabling you to control a computer.
The N1 Implant records neural activity through 1024 electrodes distributed across 64 threads, each thinner than a human hair.
Click the link to the brochure above to learn more!
