RecruitingNAINTERVENTIONAL

GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

The GB-PRIME study is an early research project testing a new system called the N1 Implant and the R1 Robot. This system is for people who have conditions that cause severe weakness or paralysis in their arms, such as spinal cord injury or ALS. The N1 Implant is a small, rechargeable device placed on the skull, with tiny wires going into the brain. The R1 Robot is specially designed to put these wires in place very precisely. The main goals are to check if the implant and robot are safe to use and if people can use them to control external devices, like a computer or smartphone, just by thinking. This could open new possibilities for independence.

At a glance

Status

Recruiting

Phase

Sponsor

Neuralink Corp

Enrolment target

Start

31 Jul 2025

Estimated completion

01 Feb 2031

Tetraplegia/Tetraparesis Quadriplegia Quadriplegia/Tetraplegia Cervical Spinal Cord Injury Amyotrophic Lateral Sclerosis (ALS)Spinal Cord Injury (Quadraplegia)Spinal Cord Injury Motor Neuron Disease Brain Stem Stroke

What is this study about?

The GB-PRIME study is an exciting new research project looking into a groundbreaking technology that could help people with severe arm weakness or paralysis. It focuses on conditions like spinal cord injury (causing quadriplegia or tetraplegia), ALS (amyotrophic lateral sclerosis), or other neurological conditions that make it very hard or impossible to use your hands to control devices.

At the heart of this study is a system made up of two main parts: the N1 Implant and the R1 Robot. The N1 Implant is a tiny, wireless device that sits on top of the skull, under the skin. It's designed to pick up signals directly from the brain. It does this using very fine threads, like tiny wires, that are carefully placed into parts of the brain that control movement. The R1 Robot is a special, very precise robot that helps a surgeon to insert these tiny threads exactly where they need to go in the brain.

The main goal of this early study is to understand if this new N1 Implant and R1 Robot system is safe for people to use, and if it actually works. Researchers want to see if participants can learn to use their thoughts, processed by the N1 Implant, to control external devices like computers or smartphones. This research is important because it could eventually lead to new ways for people with paralysis to communicate, control technology, and regain some independence in their daily lives.

Key takeaways

This is an early study testing a new brain implant and robot for people with paralysis.
The N1 Implant aims to pick up brain signals to control external devices.
The R1 Robot helps precisely place the implant's tiny wires into the brain.
The study focuses on safety and whether the system can effectively control technology.
It could offer new ways for people with paralysis to communicate and gain independence.
Participation involves surgery, learning to use the device, and regular follow-up.

Who may be eligible?

This study is looking for people who have certain types of paralysis or conditions that cause severe weakness. You might be able to join if you have a spinal cord injury, a type of stroke that affects the brain stem, or another nerve-related condition that makes it impossible for you to walk and significantly or completely stops you from using your hands to control things like a computer or phone.

Alternatively, if you've been diagnosed with Amyotrophic Lateral Sclerosis (ALS) or a similar progressive condition, you might be considered. For this, your doctor would need to expect that your condition will progress to severe arm weakness within one year of joining the study. You also need to be expected to live for at least 12 more months, be able to speak English, and have a steady caregiver who can help you.

There are also some reasons why you might not be able to join. These include being at high risk for problems during surgery, having other active medical devices in your body, being severely overweight (a BMI over 40), or having poorly controlled seizures or diabetes. Other reasons include needing regular MRI scans, having a weakened immune system, smoking, or having certain mental health conditions or brain abnormalities like bleeding or tumours. Your study doctor will make the final decision based on your overall health.

Quick self-check

Do I have severe weakness or paralysis in both arms, making it hard to use a computer or phone?
Am I expected to live for at least another year?
Can I communicate in English?
Do I have a stable caregiver who can support me?
Do I have any pre-existing conditions like poorly controlled seizures or diabetes, or need regular MRI scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, it would involve a surgical procedure to implant the N1 device into your head. After the surgery, you would have regular follow-up appointments with the study team. These visits would involve checking the implant, making sure it's working correctly, and seeing how you are recovering. You would also spend time learning how to use the implant to control external devices. This might involve tasks and exercises to help you develop the ability to interact with computers or other technology using your thoughts. The team will be there to guide you through this learning process. The total duration of your participation in the study, including follow-up, would be discussed in detail by the study team.

Potential risks and benefits

Taking part in a study like this comes with potential benefits and risks. A potential benefit could be the ability to control external devices like computers or phones with your thoughts, which might improve your independence and communication. However, there are also risks associated with any surgery, such as infection, bleeding, or reactions to anaesthesia. There's also the risk that the implant might not work as expected, or that using it could cause discomfort. The study team will explain all known and potential risks in detail before you make any decision. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University College London Hospitals NHS Foundation Trust
London, United Kingdom· Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What is the N1 Implant?

The N1 Implant is a small, wireless device that sits on your skull and connects to your brain with tiny threads. It's designed to pick up your brain signals.

What does the R1 Robot do?

The R1 Robot is a special machine that very carefully places the tiny threads from the N1 Implant into the brain during surgery.

What kind of conditions might make someone eligible?

People with severe arm weakness or paralysis due to conditions like spinal cord injury, certain strokes, or ALS might be considered for the study.

Will I be able to control a computer purely by thinking?

The aim is to see if the implant can help you control devices like computers with your thoughts. This is what the study is trying to find out.

Is the implant permanent?

The implant is designed to be surgically placed. The study team will provide more details about the implant's expected duration and eventual management.

How to find out more

Neuralink Clinical Team

clinical-team-ct@neuralink.com (877) 398-4465 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.