Neuralink N1 Implant for Speech Disorders

Overseen By Neuralink Clinical Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neuralink Corp

Disqualifiers: Seizures, Diabetes, Obesity, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

6 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Neuralink N1 Implant, designed to help people with severe speech problems regain the ability to talk. The implant, a small device placed in the brain, connects to electrode threads and offers a new communication method for those who find speaking difficult. It targets adults with conditions like ALS or strokes who also have trouble using their arms. Participants should speak English and have a stable caregiver to join.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could transform communication for those with severe speech impairments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the N1 Implant and R1 Robot are safe for use in individuals with speech disorders?

Research has shown that the Neuralink N1 Implant has undergone testing in several studies to assess its safety and effectiveness. For example, the UAE-PRIME study has focused on these factors. So far, these studies have reported no serious safety issues.

In the past year, three individuals with paralysis received Neuralink implants and used them without major problems, suggesting the treatment is generally well-tolerated. However, as this is an early study, long-term safety information may still be incomplete.

The N1 Implant represents a new technology, and while early results appear promising, participating in this trial will help gather crucial safety data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for speech disorders that often rely on speech therapy or medication to manage symptoms, the Neuralink N1 Implant offers a groundbreaking approach. This device is directly implanted into the brain using the R1 Robot, potentially allowing for real-time communication between the brain and external devices. Researchers are excited about this treatment because it targets the neurological root of speech disorders, offering the possibility of restoring natural speech capabilities rather than just managing symptoms. This direct brain interface could revolutionize how we address communication barriers, providing a new level of independence for individuals with speech disorders.

What evidence suggests that the N1 Implant and R1 Robot are effective for speech disorders?

Research has shown that the Neuralink N1 Implant, which participants in this trial will receive, could assist people with severe speech problems. In a previous study, researchers successfully placed 90% of the tiny wires, called electrodes, and 1,020 of them simultaneously picked up brain signals. This indicates the device can effectively detect brain activity, crucial for communication. Additionally, individuals with paralysis who received the implant have used it for various tasks, suggesting it might help restore speech. These early results support the potential of the N1 Implant to improve communication for those with speech disorders. ^{4 5 6 7 8}

Who Is on the Research Team?

Nader Pouratian, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

The VOICE study is for adults with severe speech impairments due to conditions like spinal cord injury, stroke, or ALS. Participants must have trouble speaking and limited arm function. Details on who can't join are not provided.

Inclusion Criteria

Life expectancy ≥ 12 months

Ability to communicate in English

Presence of a stable caregiver

Exclusion Criteria

Requires magnetic resonance imaging (MRI) for any ongoing medical conditions

Psychiatric or psychological disorder

Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Implantation of the N1 Implant by the R1 Robot

During surgical procedure

1 visit (in-person)

Initial Follow-up

Participants are monitored for device-related and procedure-related adverse events

12 months

Regular visits (in-person)

Long-term Follow-up

Participants are monitored for long-term device-related and procedure-related adverse events

Up to 48 months

Periodic visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• N1 Implant
• R1 Robot

Trial Overview

This early-stage trial tests the N1 Implant and R1 Robot system designed to help people communicate. The implant goes into the brain using a robot to possibly restore communication abilities in those with central speech pathway damage.

How Is the Trial Designed?

Group I: Neuralink N1 Implant and R1 Robot Experimental Treatment 2 Interventions

Implantation of the N1 Implant by the R1 Robot.

Who Is Running the Clinical Trial?

Neuralink Corp

Lead Sponsor

Trials

3

Recruited

10+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6914248/

An Integrated Brain-Machine Interface Platform With ...

In this experiment, 40 of 44 attempted insertions were successful (90%) for a total of 1280 implanted electrodes, of which 1020 were recorded simultaneously.

2.

thedebrief.org

thedebrief.org/neuralink-hits-7-users-as-global-brain-implant-count-remains-under-100/

Neuralink Hits 7 Users as Global Brain Implant Count ...

The goal of the study is to demonstrate the safety and effectiveness of three components: the N1 implant, the R1 surgical robot, and the N1 User ...

3.

frontiersin.org

frontiersin.org/journals/human-dynamics/articles/10.3389/fhumd.2025.1553905/full

Neuralink's brain-computer interfaces: medical innovations ...

Neuralink's advancements in brain-computer interface (BCI) technology have positioned the company as a leader in this emerging field.

4.

neuralink.com

neuralink.com/updates/a-year-of-telepathy/

A Year of Telepathy | Updates

Over the past year, three people with paralysis have received Neuralink implants. This blog post explores how each person is using Telepathy ...

5.

finance.yahoo.com

finance.yahoo.com/news/neuralink-wins-fda-breakthrough-tag-163317403.html

Neuralink wins FDA breakthrough tag for speech restoration

Neuralink is currently conducting the PRIME study (NCT06429735) in the US, a human clinical trial evaluating its brain implant and robot device ...

6.

uclh.nhs.uk

uclh.nhs.uk/news/uclh-evaluate-safety-and-functionality-neuralinks-brain-computer-interface-bci-technology

UCLH to evaluate safety and functionality of Neuralink's ...

GB-PRIME is a multi-site feasibility study that aims to evaluate the safety and functionality of Neuralink's N1 Implant. It is a fully ...

7.

clevelandclinicabudhabi.ae

clevelandclinicabudhabi.ae/en/campaigns/uae-prime-trial-neuralink

uae-prime-trial-neuralink

UAE-PRIME is a feasibility study that aims to evaluate the safety and functionality of Neuralink's N1 Implant. ... implant based on medical outcomes and personal ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06992596

NCT06992596 | UAE-PRIME: A Feasibility Study of a ...

The UAE-PRIME Study is a feasibility study designed to assess the initial clinical safety and functionality of the Neuralink N1 Implant and R1 Robot.