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NCT Number: NCT07224256

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 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.

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Key information

Conditions

Tetraplegia/Tetraparesis Amyotrophic Lateral Sclerosis Articulation Disorders Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cervical Spinal Cord Injury Communication Communication Disorders Dysarthria Language Disorders Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurobehavioral Manifestations Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Quadriplegia/Tetraplegia Signs and Symptoms Speech Speech Disorders Spinal Cord Diseases Spinal Cord Injuries Stroke TDP-43 Proteinopathies Tetraplegic; Paralysis Trauma, Nervous System Vascular Diseases Verbal Behavior Wounds and Injuries

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location status: Recruiting

Location contact

Nader Pouratian, MD

CONTACT

[email protected]

214-645-1355

Nader Pouratian, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N1 Implant

Device

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

Other names: Neuralink N1 Implant, N1, Telepathy, Link

R1 Robot

Device

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

Other names: R1, Neuralink R1 Robot

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Neuralink Clinical Team

CONTACT

[email protected]

+1 (650) 250-0520

Sponsors and collaborators

Lead sponsor

Neuralink Corp

Industry

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Nov 4, 2025
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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