Robotically implanted Neuralink N1 brain-computer interface to control external devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an early feasibility clinical study to examine the safety and functionality of the Neuralink N1 implant and the R1 robotic insertion system in people with severe upper-limb paralysis. The N1 is a wireless, rechargeable device mounted on the skull and connected to thin electrode threads that the R1 Robot inserts into the brain. Eligible participants have tetraparesis or tetraplegia from spinal cord injury, brainstem stroke, or progressive conditions such as ALS and will undergo robot-assisted implantation followed by training and regular follow-up visits. Outcomes will focus on perioperative safety, device performance, and the participant's ability to use the implant to control external devices while monitoring for adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* (a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.

OR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.

* Life expectancy ≥ 12 months.
* Ability to communicate in English
* Presence of a stable caregiver

Exclusion Criteria:

* Moderate to high risk for serious perioperative adverse events
* Active implanted devices
* Morbid obesity (Body Mass Index \> 40)
* History of poorly controlled seizures or epilepsy
* History of poorly controlled diabetes
* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
* Acquired or hereditary immunosuppression
* Use of smoking tobacco or other tobacco products
* Psychiatric or psychological disorder
* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

Where it's running

• University College London Hospitals NHS Foundation Trust
  London, Greater London, United Kingdom Recruiting
• The Newcastle upon Tyne Hospitals NHS Foundation Trust
  Newcastle upon Tyne, Tyne and Wear, United Kingdom Recruiting

Study contacts

• Study coordinator: Neuralink Clinical Team
• Email: clinical-team-ct@neuralink.com
• Phone: (877) 398-4465

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Robotically implanted brain-computer interface for controlling devices

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• Robotic implantation of a precise brain‑computer interface to restore communication

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• Robotically implanted brain-computer interface for patients with severe paralysis

  This study is testing a new brain implant that uses a robot to help people with severe paralysis communicate and control devices better.

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• Implanted brain interface to let people with severe paralysis control assistive devices

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• Implanted Brain-Computer Interface to Help People with Severe Arm Impairment

  We’re testing the N1 System, a fully implanted brain interface in the motor cortex with a robot, to see if it can help adults with spinal cord injury, ALS, or chronic stroke use a computer or keyboard more easily.

  Recruiting Neuralink Corp · Miami, Florida · NCT07929792

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.