Tests a brain implant for communication in adults with paralysis or ALS
Tests a brain implant's safety in adults with paralysis who cannot speak.
Plain-language title generated from the registry record
Registry title: VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
Key facts
- Where
- Dallas, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Source: NCT07224256, who can take part
Where in United States
- The University of Texas Southwestern Medical CenterDallas, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neuralink Corp
- Trial code
- NCT07224256
- Record updated
- 10 November 2026
- Original description
The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.Read full original descriptionShow less
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
Inclusion: 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: History of poorly controlled seizures or epilepsy; History of poorly controlled diabetes; Requires magnetic resonance imaging (MRI) for any ongoing medical conditions; 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; Moderate to high risk for serious perioperative adverse events; Morbid obesity (Body Mass Index > 40); Acquired or hereditary immunosuppression.