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

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

VOICE is an early feasibility effort to test the initial clinical safety and ability of the Neuralink N1 implant, placed by the R1 robotic inserter, to restore communication. The N1 is a skull‑mounted, wireless, rechargeable device connected to thin electrode threads that are inserted into brain speech areas by the R1 robot. Adults with central speech‑pathway neurological conditions who have severe speech production impairment and impaired upper limb function are eligible after screening, MRI review, and surgical risk assessment. The study includes surgical implantation at a single center followed by regular follow‑up to monitor safety and measure any communication gains.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.

* 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
* 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
* 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

• The University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Nader Pouratian, MD — University of Texas Southwestern Medical Center
• Study coordinator: Neuralink Clinical Team
• Email: voice-study@neuralink.com
• Phone: +1 (650) 250-0520

Similar studies

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

• 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.

  Recruiting at 2 sites Neuralink Corp · Phoenix, Arizona and 1 other locations · NCT06429735

• 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

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

  This study will test whether a robotically implanted Neuralink N1 brain-computer interface can safely help people with high spinal cord injuries or ALS control computers and other external devices.

  Recruiting at 2 sites Neuralink Corp · London, Greater London and 1 other locations · NCT07127172

• Robotically implanted brain chip to help control external devices

  This tests a wireless, rechargeable brain implant (Neuralink N1) and a robot surgical system (R1) to help people with severe arm and hand paralysis control external devices.

  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

• 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.