Robotically implanted brain-computer interface for controlling 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 study tests the safety and functionality of Neuralink's N1 Implant and R1 Robot in individuals with severe movement limitations due to conditions like tetraplegia or ALS. The N1 Implant is a small, wireless device implanted in the skull, which connects to fine threads inserted into the brain by the R1 Robot. The goal is to evaluate how effectively the implant and robot work together to assist patients in controlling external devices. Participants will be monitored for safety and functionality over the course of the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
* 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 Health Network
  Toronto, Ontario, Canada 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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• Implanted Brain-Computer Interface to Help People with Severe Arm Impairment

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• Brain-Computer Interface to Control Digital Devices for People with High Cervical Spinal Cord Injury

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  Recruiting UMC Utrecht · Utrecht, Utrecht · NCT07640711

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.