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NCT07224256 · ClinicalTrials.gov registry record · NA

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

A NA study of Stroke and Amyotrophic Lateral Sclerosis, sponsored by Neuralink.

Recruiting
Registry status
NA
Development phase
6
Enrollment target
1
Study location

NCT07224256: Recruiting NA study of Stroke and Amyotrophic Lateral Sclerosis, sponsored by Neuralink.

NCT07224256 is a NA study of Stroke and Amyotrophic Lateral Sclerosis that is actively recruiting participants, run by Neuralink. The registered enrollment target is 6 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07224256, a NA study of Stroke and Amyotrophic Lateral Sclerosis, is actively recruiting participants, sponsored by Neuralink.

RECRUITING
Registry status
NA
Development phase
6 participants
Enrollment target
1
Study location

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.

Primary Outcome

The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.

Interventions

  • DEVICE N1 Implant
  • DEVICE R1 Robot

Study Locations (1)

Texas

  • The University of Texas Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2025-10-03
Est. Completion 2031-10
Phase NA
Neuralink

2 total trials

What NCT07224256 shows while recruiting

NCT07224256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).

The record links to 7 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which N1 Implant is the first listed.

NCT07224256 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT07224256 about?

NCT07224256 is a clinical study titled "VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration". 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 irrevers...

What is the current status of trial NCT07224256?

This trial is currently recruiting. It is a NA study. The enrollment target is 6 participants. The study started on 2025-10-03. Estimated completion is 2031-10.

What conditions does trial NCT07224256 study?

This clinical trial studies the following conditions: Stroke, Amyotrophic Lateral Sclerosis, Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Quadriplegia.

What interventions are being tested in trial NCT07224256?

The interventions under investigation include: N1 Implant (DEVICE), R1 Robot (DEVICE).

Who is sponsoring clinical trial NCT07224256?

This trial is sponsored by Neuralink, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07224256 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stroke

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07224256's enrollment target sits among peer trials

6 433rd of 454 higher than 17 of 454 other Stroke trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07224256, the US trial registry maintained by the National Library of Medicine. NCT07224256 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.