Robotically implanted brain chip to help 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 a feasibility study of the Neuralink N1 implant and the R1 robotic insertion system, designed to measure initial clinical safety and basic functionality in humans. The N1 is a skull‑mounted, wireless, rechargeable device connected to fine electrode threads that the R1 Robot places into the brain. Participants will be adults with long-standing bilateral upper limb motor impairment from conditions such as cervical spinal cord injury or ALS, and will undergo implantation and follow-up assessments at the study site. The primary focus is early safety and whether the system can reliably record signals that allow control of external devices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* (a) A diagnosis of a spinal cord injury (\>12 months), stroke (\>12 months), or other neurological condition causing the participant to experience bilateral upper limb motor impairment, with no expectation of recovery.

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 participant's treating neurologist, that the disease will progress such that the participant will meet criteria 1a within 1 year of recruitment.

* Life expectancy ≥ 12 months.
* Ability to communicate verbally or with the use of a computer or communication aid, and working proficiency in English.
* Presence of a stable caregiver

Exclusion Criteria:

* Moderate to high risk for serious perioperative adverse events
* 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
* Smoking tobacco or use of other tobacco products \> once per month within the last year.
* Psychiatric or psychological disorder
* Pre-existing damage to the cortical region of interest (as determined by MRI)
* 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

• Cleveland Clinic Abu Dhabi (CCAD)
  Abu Dhabi, United Arab Emirates Recruiting

Study contacts

• Principal investigator: Florian Roser, MD — Cleveland Clinic Abu Dhabi
• 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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• 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

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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.