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VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration
Sponsor: Neuralink Corp
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.
Key Details
Gender
All
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2025-10-03
Completion Date
2031-10
Last Updated
2025-11-04
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
The University of Texas Southwestern Medical Center
Dallas, Texas, United States