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

Neuralink Corp · NCT07224256

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
6
US sites recruiting
1
Study start
October 3, 2025
Record last updated
November 4, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: N1 Implant; R1 Robot

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • The University of Texas Southwestern Medical Center

    Dallas, TX 75390

    Site contact: Nader Pouratian, MD · 214-645-1355 · voice-study@neuralink.com

Study contacts (from the official record)

  • Neuralink Clinical Team · +1 (650) 250-0520 · voice-study@neuralink.com
All neurology studies in Texas →
VOICE: An Early Feasibility Study of a Precise Robotically… (NCT07224256) | Bored Studies