Brain-Computer Interface for Paralysis

(PRIME Trial)

Recruiting at 1 trial location

Overseen By Neuralink Clinical Team

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Neuralink Corp

Disqualifiers: Seizures, Diabetes, Obesity, Smoking, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this 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 R1 Robot device designs in participants with tetraparesis or tetraplegia. 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.

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 data supports the effectiveness of the treatment Precise Robotically Implanted Brain-Computer Interface, Neuralink N1 Implant, R1 Robot, PRIME Study?

Research shows that brain-computer interfaces (BCIs) can help people with paralysis control devices and communicate by interpreting brain signals. Studies have demonstrated that both invasive and noninvasive BCIs can enable movement control, suggesting potential benefits for those with severe motor impairments. ^{1 2 3 4 5}

What safety data exists for the Brain-Computer Interface for Paralysis?

The BrainGate feasibility study, the largest and longest-running clinical trial of an implanted brain-computer interface (BCI), provides some safety data, but the long-term safety of these devices in humans is still not fully known. Additionally, implantable BCI research identifies several risk areas, including short and long-term safety, cognitive and communicative impairment, and privacy concerns. ^{3 6 7 8 9}

How is the Precise Robotically Implanted Brain-Computer Interface treatment different from other treatments for paralysis?

The Precise Robotically Implanted Brain-Computer Interface, also known as the Neuralink N1 Implant, is unique because it involves implanting electrodes directly into the brain to capture and translate brain signals into commands for controlling devices, offering potentially more precise and multidimensional control compared to noninvasive methods that use external sensors. ^{2 3 4 10 11}

Research Team

Francisco Ponce, MD

Principal Investigator

Barrow Neurological Institute

Jonathan Jagid, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Precise Robotically Implanted Brain-Computer Interface (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.

Participant Groups

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 Canada for the following indications:

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The emerging world of motor neuroprosthetics: a neurosurgical perspective. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Control of a two-dimensional movement signal by a noninvasive brain-computer interface in humans. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Work toward real-time control of a cortical neural prothesis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Assistive technology and robotic control using motor cortex ensemble-based neural interface systems in humans with tetraplegia. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Home Use of a Percutaneous Wireless Intracortical Brain-Computer Interface by Individuals With Tetraplegia. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

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

8. Canada 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". [2020]

9. England pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Developing a Three- to Six-State EEG-Based Brain-Computer Interface for a Virtual Robotic Manipulator Control. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Applications of brain-computer interfaces to the control of robotic and prosthetic arms. [2020]