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VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration

NCT07224256 · Neuralink Corp
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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 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
Study design
Enrollment target: 6 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-03
Estimated completion: 2031-10
Last updated: 2025-11-04
Interventions
Device: N1 ImplantDevice: R1 Robot
Primary outcomes
  • Device-Related Adverse Events (AE) (12 months post-implant)
  • Procedure-Related Adverse Events (AE) (12 months post-implant)
Sponsor
Neuralink Corp · industry
Contacts & investigators
ContactNeuralink Clinical Team · contact · voice-study@neuralink.com · +1 (650) 250-0520
InvestigatorNader Pouratian, MD · principal_investigator, University of Texas Southwestern Medical Center
All locations (1)
The University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration · TrialPath