Robotic implantation of a precise brain‑computer interface to restore communication
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
This project tests whether a robotically implanted Neuralink N1 brain implant can help adults with severe, irreversible speech loss from ALS, spinal cord injury, or stroke communicate again.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Neuralink Corp Industry-sponsored |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT07224256 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with ALS, PLS, cervical spinal cord injury, stroke, or similar central speech‑pathway conditions who have severe speech impairment, impaired upper limb function, English proficiency, a stable caregiver, life expectancy of at least 12 months, and suitable MRI anatomy and surgical risk are ideal candidates.
Not a fit: People with high perioperative risk, morbid obesity (BMI > 40), uncontrolled seizures or diabetes, immunosuppression, psychiatric conditions, need for ongoing MRIs, or brain anatomy unsuitable for electrode placement are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could restore a usable method of communication for people with severe, irreversible speech loss.
How similar studies have performed: Prior intracortical brain‑computer interface work has shown proof‑of‑concept for enabling limited communication in paralysis and ALS, but this precise robotically implanted N1/R1 approach is novel and early in human testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dallas, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.