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

NCT07224256 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-11-04

No results posted yet for this 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.

Conditions

Interventions

DEVICE

N1 Implant

The N1 Implant is a type of implantable brain-computer interface

DEVICE

R1 Robot

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Sponsors & Collaborators

  • Neuralink Corp

    lead INDUSTRY

Principal Investigators

  • Nader Pouratian, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-03
Primary Completion
2028-10-31
Completion
2031-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224256 on ClinicalTrials.gov