Back to search results

VOICE Study: Brain-Computer Interface for Communication

The VOICE Study is an early study looking at the safety and effectiveness of the N1 Implant and R1 Robot system. The N1 Implant is a device placed in the brain to help people with severe speech problems communicate. It's designed for adults aged 22-75 who have conditions like ALS, stroke, or spinal cord injury, which cause severe speech and arm movement difficulties. The R1 Robot helps to place the N1 Implant. This study will enroll 6 participants and will measure any problems related to the device or the procedure for 12 months after the implant. You must have a life expectancy of at least 12 months and be able to communicate in English, with a stable caregiver.

Study design
This is an early study (feasibility study) with 6 participants. It is an interventional study, meaning participants will receive the N1 Implant and R1 Robot.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the implant to monitor for device-related and procedure-related adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224256

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

Recruiting
NAAges 22–75Interventional
Neuralink Corp
~6 participants
Updated 2025-11-04 on ClinicalTrials.gov
What's tested:N1 ImplantR1 Robot

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device-Related Adverse Events (AE)
Measured over 12 months post-implant
+1 more outcome measured

Conditions

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

Explore related trials

Amyotrophic Lateral SclerosisPrimary Lateral SclerosisQuadriplegiaSpinal Cord InjuryStroke

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Nader Pouratian, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Neuralink Clinical Team
[email protected]
+1 (650) 250-0520
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Life expectancy ≥ 12 months.
Ability to communicate in English
Presence of a stable caregiver

Exclusion

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

What this trial measures

  • 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.