Neuralink Brain-Computer Interface for Quadriplegia

(CAN-PRIME Trial)

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)

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 a new brain-computer interface called the N1 Implant, which may assist people with severe quadriplegia (very limited or no movement in arms and legs) due to spinal cord injuries or ALS. The implant is a small, wireless device placed in the skull and connected to the brain by tiny threads inserted using the R1 Robot. Researchers aim to determine the safety and effectiveness of this technology. Individuals who have experienced quadriplegia for at least a year without improvement and can communicate in English might be suitable candidates.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform lives.

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 N1 Implant and R1 Robot are safe for use in people with tetraplegia?

Research shows that the N1 Implant and R1 Robot remain in the early stages of human testing. This means the full extent of their safety is not yet known. However, early studies are examining their initial safety and effectiveness.

These studies primarily test the devices on individuals with quadriplegia, a condition that prevents movement of the arms and legs. The N1 Implant is a small, wireless device placed in the skull, while the R1 Robot assists in inserting tiny threads into the brain.

Safety results are still being collected. Since these tests are in the early stages, they focus on determining whether the devices can be used safely without causing serious problems. Reports of severe side effects have been limited, but detailed information is not yet fully available.

Given the early stage of this research, participants must maintain close contact with medical professionals during the trial to monitor for any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Neuralink Brain-Computer Interface for quadriplegia because it introduces a groundbreaking approach to restoring mobility and communication. Unlike traditional assistive technologies that rely on external devices, the N1 Implant is embedded directly into the brain, allowing for a more seamless and natural interaction with external devices. The R1 Robot precisely implants the device, offering unprecedented accuracy and minimizing potential complications. This innovative combination could dramatically improve the quality of life for individuals with quadriplegia by enabling direct brain-to-device communication.

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

Research has shown that the Neuralink N1 Implant, which participants in this trial will receive, could assist people with paralysis. Early results suggest that the implant enables users to control devices through thought alone. In one study, participants with the implant used their thoughts to interact with technology, potentially increasing their independence. The device is placed in the skull and connected to the brain with tiny threads, inserted by a special robot. The aim is to help people with limited movement gain more control over their surroundings. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with severe movement disabilities due to conditions like Motor Neuron Disease, Spinal Cord Injury, or ALS. Participants should have limited arm and leg mobility (tetraparesis or tetraplegia). Specific eligibility details are not provided but typically include age, health status, and the severity of paralysis.

Inclusion Criteria

Presence of a stable caregiver

Life expectancy ≥ 12 months

I have had severe quadriplegia for at least a year without improvement.

Exclusion Criteria

I have a history of diabetes that is hard to control.

Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

My BMI is over 40.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Participants undergo the implantation of the N1 device using the R1 Robot

1 week

1 visit (in-person)

Post-Implantation Monitoring

Participants are monitored for safety and functionality of the N1 Implant and R1 Robot

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial monitoring period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• N1 Implant
• R1 Robot

Trial Overview The CAN-PRIME Study tests Neuralink's N1 Implant and R1 Robot. The implant goes into the skull and connects to brain threads placed by the robot. It aims to see if people can control external devices using their thoughts.

How Is the Trial Designed?

Group I: CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface Experimental Treatment 2 Interventions

Open label

N1 Implant is already approved in United States, Canada for the following indications:

Approved in United States as Neuralink N1 Implant for:

• Quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS)

Approved in Canada as Neuralink N1 Implant for:

• Tetraparesis or tetraplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS)

Who Is Running the Clinical Trial?

Neuralink Corp

Lead Sponsor

Trials

3

Recruited

10+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

A case study involving a participant with spastic quadriplegic cerebral palsy demonstrated that training with a commercial EEG-based brain-computer interface (BCI) over four weeks led to improved control of distinct EEG patterns, allowing the participant to type a sentence six weeks post-training.

The study emphasized that factors like motivation, fatigue, and concentration significantly affect BCI performance, highlighting the need for engaging and customized training environments to enhance the effectiveness of assistive technologies for individuals with severe disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training to use a commercial brain-computer interface as access technology: a case study. Taherian, S., Selitskiy, D., Pau, J., et al.[2017]

Brain-computer interfaces (BCIs) have significant potential for neuroprosthetic applications, particularly in controlling devices for hand grasp, multijoint movements, and lower extremities.

The review identifies current limitations in BCIs and emphasizes the need for further research to improve the integration of BCIs with functional electrical stimulation (FES) systems for better performance in neuroprosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interface-FES Integration: Towards a Hands-free Neuroprosthesis Command System. Boord, P., Barriskill, A., Craig, A., et al.[2022]

The novel tilt brain-machine interface (BMI) task developed for female rats allows for natural engagement of the lower body, enabling researchers to study spinal cord injury (SCI) models without requiring the animals to learn new skills or rely on external rewards.

This task effectively engages both hemispheres of the cortex and allows for adjustable difficulty, making it a promising tool for investigating how brain plasticity interacts with BMI training in the context of SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A rodent brain-machine interface paradigm to study the impact of paraplegia on BMI performance. Bridges, NR., Meyers, M., Garcia, J., et al.[2020]

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]

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 wearable neural interface using high-density surface electromyography (HDEMG) was developed to detect signals from spared motor units in the forearms of individuals with tetraplegia, allowing for the identification of myoelectric activity even without visible finger movement.

This technology demonstrated the ability to decode motor intent from over 30 active motor neurons, providing a promising method for controlling assistive devices and studying spinal network recovery after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable neural interface for detecting and decoding attempted hand movements in a person with tetraplegia. Ting, J., Farina, D., Weber, DJ., et al.[2020]

A portable, fully implanted brain-computer interface successfully restored hand grasp control in a 21-year-old male with complete cervical quadriplegia, achieving a mean decoding accuracy of 89.0% during a 29-week laboratory study.

The system demonstrated high accuracy (91.3% in open-loop and 88.3% in closed-loop trials) for controlling hand movements at home, indicating its potential for practical use in improving functional independence for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable brain-computer interface for neuroprosthetic-enabled volitional hand grasp restoration in spinal cord injury. Cajigas, I., Davis, KC., Meschede-Krasa, B., et al.[2023]

A brain-spine interface was successfully developed in non-human primates, allowing for the restoration of weight-bearing locomotion in a paralyzed leg just six days after a spinal cord injury, demonstrating significant potential for rehabilitation.

The system utilized epidural electrical stimulation linked to real-time neural activity from the motor cortex, indicating a promising method for bypassing spinal cord lesions and restoring movement control, with components already approved for human research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brain-spine interface alleviating gait deficits after spinal cord injury in primates. Capogrosso, M., Milekovic, T., Borton, D., et al.[2022]

Recent advancements in brain-machine interfaces (BMIs) show promise for improving control over prosthetic devices using neural activity, which could significantly benefit individuals with neurological disorders.

Despite the progress, current neural interfaces still struggle to achieve effective control of prosthetic limbs, indicating that further research is needed to develop clinically viable solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in neuroprosthetic learning and control. Carmena, JM.[2021]

Brain-computer interfaces (BCI) are promising devices that can help quadriplegic patients regain control by interpreting brain signals to operate physical and virtual prosthetics.

The future of BCI technology aims to include sensory feedback, which will enhance the user experience and effectiveness for patients with neurological injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain-Computer Interfaces in Quadriplegic Patients. Lee, MB., Kramer, DR., Peng, T., et al.[2019]

Citations

1. 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 ...

2. 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 ...

3. neuralink.com neuralink.com/updates/prime-study-progress-update-user-experience/

PRIME Study Progress Update — User Experience It is estimated that 180,000 Americans live with quadriplegia, and each year, an additional ~18,000 suffer a paralyzing spinal cord injury.

4. news.med.miami.edu news.med.miami.edu/paralyzed-veteran-surgically-implanted-with-neuralink-device-at-the-miami-project-to-cure-paralysis/

Paralyzed Veteran Surgically Implanted with Neuralink Device ... Study seeks to enable paralyzed patients to use their own thoughts to control external devices through a brain-computer interface.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10226009/

Use of Invasive Brain-Computer Interfaces in Pediatric ... Children with severe neurologic disabilities, like quadriplegic cerebral palsy or cervical spine trauma, could benefit from this technology. However, they have ...

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

PRIME Study Progress Update The first indication we aim to address is the restoration of digital autonomy to people living with quadriplegia due to spinal cord injury (SCI) ...

7. cbc.ca cbc.ca/news/health/neuralink-brain-chip-clinical-trial-1.7626598

Elon Musk's Neuralink brain chip implanted into 2 ... It's the first clinical trial outside the U.S., testing the safety and clinical efficacy of the wireless brain chip.

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. barrowneuro.org barrowneuro.org/about/news-and-articles/press-releases/prime-study-site-announcement/

PRIME Study Site Announcement The Neuralink PRIME Study is the first of its kind and is currently open to adults with quadriplegia due to vertical spinal cord injury or ALS who are 22 or ...