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Clinical Trials in the USA / NCT07224256
Recruiting Not applicable

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

NCT07224256 · tracked via the Priya Life Science USA tracker
Sponsor
Neuralink Corp
Phase
Not applicable
Started
2025-10-03
Last updated
2025-11-04

Condition(s) studied

Tetraplegia/TetraparesisQuadriplegiaCervical Spinal Cord InjuryAmyotrophic Lateral SclerosisQuadriplegia/TetraplegiaTetraplegic; ParalysisStroke

Investigational drug(s) / intervention(s)

N1 ImplantR1 Robot

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.

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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Device-Related Adverse Events (AE) — 12 months post-implant
    The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit.
  • Procedure-Related Adverse Events (AE) — 12 months post-implant
    The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit.

Trial sites (1)

FacilityCityRegionStatus
The University of Texas Southwestern Medical Center Dallas Texas Recruiting

More Neuralink Corp trials in the USA

Control of Assistive Devices Via Brain-Computer Interface Technology Enrolling by invitation
Precise Robotically IMplanted Brain-Computer InterfacE Recruiting

Other trials for the same condition

A Study of LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS). Starting soon
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis Active, not recruiting
Virtual Activities of Living for Occupational Rehabilitation Starting soon
AMPLATZER PFO Occluder Post Approval Study Active, not recruiting
Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07224256 on ClinicalTrials.gov ↗ ← All trials in the USA