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

October 31, 2025 updated by: Neuralink Corp
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • The University of Texas Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Nader Pouratian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuralink N1 Implant and R1 Robot
Implantation of the N1 Implant by the R1 Robot.
Device: N1 Implant
The N1 Implant is a type of implantable brain-computer interface
Other Names:
  • Neuralink N1 Implant, N1, Telepathy, Link
Device: R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Other Names:
  • R1, Neuralink R1 Robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-Related Adverse Events (AE)
Time Frame: 12 months post-implant
The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.
12 months post-implant
Procedure-Related Adverse Events (AE)
Time Frame: 12 months post-implant
The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.
12 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term Device-Related Adverse Events (AE)
Time Frame: Up to 48 months post-implant
The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit.
Up to 48 months post-implant
Long-term Procedure-Related Adverse Events (AE)
Time Frame: Up to 48 months post-implant
The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit.
Up to 48 months post-implant
Preliminary efficacy of the R1 Robot
Time Frame: During surgical implantation procedure
Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes).
During surgical implantation procedure
Preliminary efficacy of the N1 Implant
Time Frame: Up to 48 months post-implant
Preliminary efficacy of the N1 Implant will be evaluated by measuring the following BCI performance for speech, quantified by measuring the monthly maximum correct word per minute (CWPM).
Up to 48 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuralink Corp

Investigators

  • Principal Investigator: Nader Pouratian, MD, University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

October 13, 2025

First Submitted That Met QC Criteria

October 31, 2025

First Posted (Estimated)

November 4, 2025

Study Record Updates

Last Update Posted (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

October 31, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N1-EFS-200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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