Recruiting

N1 Implant

Sponsor:

Neuralink Corp

Code:

NCT07224256

Conditions

Tetraplegia/Tetraparesis

Quadriplegia

Cervical Spinal Cord Injury

Amyotrophic Lateral Sclerosis

Quadriplegia/Tetraplegia

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

N1 Implant

R1 Robot

Study Details

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

Study ID

NCT07224256

Start date

Oct 3, 2025

Status verified date

Oct, 2025

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Neuralink N1 Implant and R1 Robot

Implantation of the N1 Implant by the R1 Robot.

Interventions

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.

Primary outcome measure

  • Device-Related Adverse Events (AE) [ Time Frame: 12 months post-implant ]
  • Procedure-Related Adverse Events (AE) [ Time Frame: 12 months post-implant ]

Central Contacts and Locations

Central contacts

Neuralink Clinical Team

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

Locations

The University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Nader Pouratian, MD

214-645-1355voice-study@neuralink.com

Principal Investigator:

Nader Pouratian, MD

More Information

Sponsor

Neuralink Corp

Last update posted

Nov 4, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Neuralink Corp on 2025-11-04.