Robotically implanted brain-computer interface for patients with severe paralysis

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

The PRIME Study is an early feasibility assessment aimed at evaluating the safety and functionality of the Neuralink N1 Implant and R1 Robot in individuals suffering from severe quadriplegia or tetraparesis due to spinal cord injury or ALS. This innovative approach involves a wireless, rechargeable implant that connects to electrode threads inserted into the brain by a robotic device. The study seeks to determine how effectively this technology can restore communication and control for patients with significant motor impairments.

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

• Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• University of Miami
  Miami, Florida, United States Recruiting

Study contacts

• Principal investigator: Francisco Ponce, MD — Barrow Neurological Institute
• 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.

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

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

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• Robotically implanted brain chip to help control external devices

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  Recruiting Neuralink Corp · Abu Dhabi · NCT06992596

• Robotically implanted brain-computer interface for controlling devices

  This study is testing a new brain implant and robot to see if they can help people with severe movement limitations control devices more easily.

  Recruiting Neuralink Corp · Toronto, Ontario · NCT06700304

• Connexus® Brain-Computer Interface to restore communication and device control

  This study will try the Connexus brain-computer interface to help people with severe loss of voluntary movement (for example from ALS, cervical spinal cord injury, or stroke) communicate and control computers.

  Recruiting at 3 sites Paradromics · Sacramento, California and 2 other locations · NCT07357428

• MindEx multifocal cognitive brain‑machine interface for people with severe paralysis

  This trial will test the MindEx system, which uses four tiny implanted brain chips to let people with severe paralysis control a computer or tablet with their thoughts.

  Recruiting University of Texas Southwestern Medical Center · Dallas, Texas · NCT05936619

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.