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

NCT07224256 | Recruiting DMC FDA Device

• 1 other identifier: N1-EFS-200
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Tetraplegia/Tetraparesis; Quadriplegia; Cervical Spinal Cord Injury; Amyotrophic Lateral Sclerosis; Quadriplegia/Tetraplegia; Tetraplegic; Paralysis; Stroke

Keywords

stroke; spinal cord injury; SCI; ALS; brain computer interface; BCI; PLS; voice; speech; dysarthria; neuralink

Outcome Measures

Primary Outcomes (2)

• Device-Related Adverse Events (AE)

  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)

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

  12 months post-implant

Secondary Outcomes (4)

• Long-term Device-Related Adverse Events (AE)

  Up to 48 months post-implant

• Long-term Procedure-Related Adverse Events (AE)

  Up to 48 months post-implant

• Preliminary efficacy of the R1 Robot

  During surgical implantation procedure

• Preliminary efficacy of the N1 Implant

  Up to 48 months post-implant

Study Arms (1)

Neuralink N1 Implant and R1 Robot

EXPERIMENTAL

Implantation of the N1 Implant by the R1 Robot.

Device: N1 Implant; Device: R1 Robot

Interventions

N1 Implant DEVICE

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

Also known as: Neuralink N1 Implant, N1, Telepathy, Link

Neuralink N1 Implant and R1 Robot

R1 Robot DEVICE

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

Also known as: R1, Neuralink R1 Robot

Neuralink N1 Implant and R1 Robot

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuralink Corp: lead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Related Links

• https://neuralink.com/

MeSH Terms

Conditions

Quadriplegia; Amyotrophic Lateral Sclerosis; Paralysis; Stroke; Spinal Cord Injuries; Speech; Dysarthria

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Trauma, Nervous System; Wounds and Injuries; Verbal Behavior; Communication; Behavior; Articulation Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations

Study Officials

• Nader Pouratian, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neuralink Clinical Team

CONTACT

+1 (650) 250-0520; voice-study@neuralink.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2025
• First Posted: November 4, 2025
• Study Start: October 3, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2031
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)