Brain-Computer Interface for Paralysis

(PRIME Trial)

Recruiting at 1 trial location

Overseen By Neuralink Clinical Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neuralink Corp

Disqualifiers: Seizures, Diabetes, Obesity, Smoking, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device, the Precise Robotically Implanted Brain-Computer Interface (also known as the Neuralink N1 Implant), which connects the brain to a computer to assist people with severe paralysis (tetraparesis or tetraplegia). The goal is to determine if the device is safe and effective. Participants will receive a small implant in their skull that connects to the brain using tiny wires. The trial seeks individuals who have experienced severe paralysis due to a spinal cord injury or ALS for at least a year and who can communicate in English. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could transform paralysis treatment.

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 study team or your doctor.

What prior data suggests that the Neuralink N1 Implant and R1 Robot are safe for use in humans with tetraparesis or tetraplegia?

Research shows that the Neuralink N1 Implant and R1 Robot are being tested for safety in humans through the PRIME study. This marks the first trial of the device in people. The N1 Implant, a small device placed on the skull, connects to the brain with tiny wires. The R1 Robot assists in accurately inserting these wires.

As an early study, limited human data exists to confirm safety. However, the study's initiation suggests that earlier research deemed it promising enough for human testing. Typically, the start of such a trial indicates that scientists consider the risks low enough to proceed. Nonetheless, since this is new technology being tested in humans for the first time, participants should be aware of potential unexpected risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Precise Robotically Implanted Brain-Computer Interface for paralysis because it offers a groundbreaking approach to restoring communication between the brain and external devices. Unlike traditional treatments that rely on physical therapy or assistive technologies, this interface uses the Neuralink N1 Implant, which is inserted by the R1 Robot directly into the brain. This direct brain-computer connection has the potential to offer more precise and immediate control over devices, which could significantly enhance mobility and independence for individuals with paralysis. The innovative implant technique and the robotic precision involved in the procedure are key features that set this treatment apart, paving the way for new possibilities in neurotechnology.

What evidence suggests that the Neuralink N1 Implant and R1 Robot are effective for paralysis?

Research shows that brain-computer interfaces (BCIs), such as the Neuralink N1 Implant, might help people with paralysis communicate or control devices using their thoughts. Participants in this trial will receive this implant, which connects brain signals to computers, potentially enabling new ways to interact with technology. Early studies suggest that similar devices have allowed users to type or move a cursor by thinking. Although limited human data exists for this specific device, the technology relies on the concept that brain signals can be understood and used to perform tasks, offering hope for greater independence in daily life. As research progresses, more detailed information on its effectiveness will become available. ^{1 6 7 8 9}

Who Is on the Research Team?

Jonathan Jagid, MD

Principal Investigator

University of Miami

Francisco Ponce, MD

Principal Investigator

Barrow Neurological Institute

Are You a Good Fit for This Trial?

This trial is for individuals with severe paralysis, including those with spinal cord injuries or diseases like ALS. Participants should have tetraplegia, meaning paralysis of all four limbs. Specific eligibility will be determined by the study team.

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

Active implanted devices

I am at moderate to high risk for serious complications from surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Implantation of the N1 Implant by the R1 Robot

1 day

1 visit (in-person)

Initial Follow-up

Participants are monitored for initial clinical safety and device functionality

4 weeks

Weekly visits (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and device performance

6 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Precise Robotically Implanted Brain-Computer Interface

Trial Overview The PRIME Study tests a brain-computer interface called the N1 Implant and its robotic installer, the R1 Robot. The implant records brain activity to potentially help control devices despite paralysis.

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.

Precise Robotically Implanted Brain-Computer Interface is already approved in United States, Canada for the following indications:

Approved in United States as Neuralink N1 Implant and R1 Robot for:

• Quadriplegia due to spinal cord injury or ALS

Approved in Canada as Neuralink N1 Implant and R1 Robot for:

• Tetraparesis or tetraplegia due to cervical spinal cord injury or ALS

Who Is Running the Clinical Trial?

Neuralink Corp

Lead Sponsor

Trials

3

Recruited

10+

Published Research Related to This Trial

The BrainGate feasibility study, involving 14 adults with quadriparesis, demonstrated that the implanted microelectrode arrays had a low rate of serious adverse events (SAEs) over an average implantation duration of 872 days, with no device-related deaths or permanent disabilities.

The most common adverse event was skin irritation, and overall, the safety profile of the BrainGate Neural Interface system is comparable to other chronically implanted medical devices, suggesting a favorable risk/benefit ratio for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. Rubin, DB., Ajiboye, AB., Barefoot, L., et al.[2023]

Neural interface systems (NISs) are promising devices that allow individuals with paralysis to control assistive technologies using brain signals, showing potential for reanimating muscles based on direct commands from the brain.

Initial pilot trials using an intracortical microelectrode sensor have demonstrated that even years after injury, neurons in the motor cortex can still be engaged to operate devices, indicating the lasting potential of brain signals for functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia. Donoghue, JP., Nurmikko, A., Black, M., et al.[2018]

Neuralink has developed a high-bandwidth brain-machine interface with up to 3072 electrodes per array, significantly increasing the potential for restoring sensory and motor functions compared to existing systems.

The system includes a neurosurgical robot that can insert electrodes with micron precision, achieving a spiking yield of up to 70% in chronically implanted electrodes, which enhances the reliability and effectiveness of the interface.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrated Brain-Machine Interface Platform With Thousands of Channels. Musk, E.[2022]

The study identifies six core risk domains associated with implantable brain-computer interfaces (BCIs), including safety, cognitive impairment, and privacy concerns, which are crucial for informed consent in clinical applications.

Additionally, the research highlights three further risk domains—identity, agency, and stigma—that are often overlooked in consent processes, emphasizing the need for comprehensive discussions about the implications of BCI technology with potential participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informed Consent in Implantable BCI Research: Identifying Risks and Exploring Meaning. Klein, E.[2018]

The developed EEG-based brain-computer interface (BCI) system allows for high-performance control of robotic prosthetics with a short training time of just 15 minutes, showing promise for practical applications.

In tests with 12 healthy participants, 3 achieved high accuracy (80%-90%) in a six-state communication task, and 2 of the top performers successfully completed all tasks controlling a virtual prosthetic manipulator with an average accuracy of 80%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Three- to Six-State EEG-Based Brain-Computer Interface for a Virtual Robotic Manipulator Control. Mishchenko, Y., Kaya, M., Ozbay, E., et al.[2020]

The study successfully demonstrated the first human use of a wireless intracortical brain-computer interface (iBCI), allowing individuals with paralysis to control devices like tablets without being tethered by cables, which enhances usability and independence.

Participants achieved communication and control performance comparable to traditional wired systems, indicating that this wireless iBCI technology could significantly improve the quality of life for people with severe motor impairments by providing on-demand access to assistive technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home Use of a Percutaneous Wireless Intracortical Brain-Computer Interface by Individuals With Tetraplegia. Simeral, JD., Hosman, T., Saab, J., et al.[2021]

Brain-computer interfaces (BCIs) can significantly enhance the quality of life for individuals with severe motor disabilities by translating brain activity into commands for controlling devices like robotic limbs.

Researchers are actively developing new solutions to improve the real-time decoding of complex neural signals, which is essential for enabling full dexterous manipulation of robotic and prosthetic arms for everyday tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of brain-computer interfaces to the control of robotic and prosthetic arms. Vilela, M., Hochberg, LR.[2020]

Motor neuroprosthetic devices, also known as brain-computer interfaces, can decode brain signals related to motor intent, allowing individuals with severe motor impairments to control devices and improve their interaction with the environment.

As the field of neuroprosthetics advances, understanding the principles of operation and surgical considerations for implantation will be crucial for neurosurgeons to effectively help patients with conditions like spinal cord injury and stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging world of motor neuroprosthetics: a neurosurgical perspective. Leuthardt, EC., Schalk, G., Moran, D., et al.[2007]

A noninvasive brain-computer interface (BCI) using scalp-recorded brain signals can provide multidimensional movement control for individuals with severe motor disabilities, comparable to invasive BCIs used in monkeys.

The adaptive algorithm in this noninvasive BCI enhances users' ability to control movements by focusing on the brain signals they can best manage, suggesting a safe and effective alternative for operating robotic arms or neuroprostheses without surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of a two-dimensional movement signal by a noninvasive brain-computer interface in humans. Wolpaw, JR., McFarland, DJ.[2023]

Intracortical brain-machine interfaces could help individuals with severe neurological disorders regain lost functions through neuroprosthetic devices, but current microelectrode arrays face challenges like limited recording life and biocompatibility.

The new approach proposed by Musk and Neuralink aims to improve the brain-electrode interface technology, potentially overcoming issues related to long-term use and enhancing the distribution of recording electrodes in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reconnecting the Hand and Arm with Brain (ReHAB) Commentary on "An Integrated Brain-Machine Interface Platform With Thousands of Channels". Kirsch, RF., Ajiboye, AB., Miller, JP.[2020]

Deep brain stimulation (DBS) has been shown to significantly improve the quality of life for patients with movement disorders like Parkinson's disease and dystonia, highlighting its efficacy in treating certain neurological conditions.

A new system has been developed to interpret the activity of motor cortical neurons in real-time, which is a crucial step towards creating a brain-computer interface (BCI) that could help restore movement for individuals with severe motor impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Work toward real-time control of a cortical neural prothesis. Isaacs, RE., Weber, DJ., Schwartz, AB.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06429735

Precise Robotically IMplanted Brain-Computer InterfacE The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07224256

VOICE: An Early Feasibility Study of a Precise Robotically ... The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot ...

3. withpower.com withpower.com/trial/phase-spinal-cord-injuries-2024-7805f

Brain-Computer Interface for Paralysis (PRIME Trial) The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and ...

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

An Integrated Brain-Machine Interface Platform With ... In this white paper, we describe Neuralink's first steps toward a scalable high-bandwidth brain-machine interface system.

5. iankhan.com iankhan.com/revolutionary-brain-computer-interface-neuralinks-n1-implant-enables-first-human-thought-to-text-communication/

Revolutionary Brain-Computer Interface: Neuralink's N1 Implant ... The current focus remains on the PRIME Study (Precise Robotically Implanted Brain-Computer Interface) for individuals with quadriplegia, with plans to implant ...

6. neuralink.com neuralink.com/updates/prime-study-progress-update/

PRIME Study Progress Update In January, we conducted the first human implantation of our brain-computer interface. This blog post shares a high-level snapshot of where ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07224256?lastUpdPost=2020-03-16_

VOICE: An Early Feasibility Study of a Precise Robotically ... The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot ...

8. themiamiproject.org themiamiproject.org/neuralink/

The Miami Project to Cure Paralysis at University of ... The Neuralink PRIME (Precise Robotically Implanted Brain-Computer Interface) Study is an early feasibility study to assess the safety and functionality of ...

9. news.med.miami.edu news.med.miami.edu/the-miami-project-to-cure-paralysis-selected-as-site-for-neuralink-clinical-trial/

The Miami Project to Cure Paralysis at the University of Miami ... The Neuralink PRIME (Precise Robotically Implanted Brain-Computer Interface) Study is an early feasibility study to assess the safety and ...