N1 Implant: The N1 Implant is a type of implantable brain-computer interface
R1 Robot: The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Device-Related Adverse Events (AE) — 12 months post-implant The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.
Procedure-Related Adverse Events (AE) — 12 months post-implant The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.
Trial sites (1)
Facility
City
Region
Status
The University of Texas Southwestern Medical Center
Dallas
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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