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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Neuralink Corp
Study ID
NCT07224256
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • N1 Implant — DEVICE
    The N1 Implant is a type of implantable brain-computer interface
  • R1 Robot — DEVICE
    The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Study Details

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 Dates

Start date
Oct 3, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2031

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Neuralink N1 Implant and R1 Robot
    Implantation of the N1 Implant by the R1 Robot.

Primary Outcome Measure

Device-Related Adverse Events (AE) [ Time Frame: 12 months post-implant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Southwestern Medical CenterDallasTexas75390
Nader Pouratian, MD
[email protected]
214-645-1355
Nader Pouratian, MD (PRINCIPAL_INVESTIGATOR)

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