Neuralink Brain-Computer Interface for Quadriplegia

(CAN-PRIME Trial)

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

Trial Summary

What is the purpose of this trial?

The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.

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 Neuralink Brain-Computer Interface treatment for quadriplegia?

Research shows that brain-computer interfaces can restore movement in paralyzed limbs by linking brain activity to muscle stimulation. In studies with animals and humans, these systems have successfully restored hand and leg movements, suggesting potential benefits for people with quadriplegia. ^{1 2 3 4 5}

How is the Neuralink Brain-Computer Interface treatment different from other treatments for quadriplegia?

The Neuralink Brain-Computer Interface treatment is unique because it involves an implantable device that directly interfaces with the brain to read motor intent and control devices, offering a novel way to restore function for quadriplegic patients. Unlike other treatments that may rely on external devices or muscle signals, this approach uses a brain implant and a surgical robot to provide a more direct and potentially more effective method of control. ^{6 7 8 9 10}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• N1 Implant (Brain-Computer Interface)
• R1 Robot (Procedure)

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.

Participant Groups

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

Open label

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

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+

Findings from Research

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Implantable brain-computer interface for neuroprosthetic-enabled volitional hand grasp restoration in spinal cord injury. [2023]

2. England pubmed.ncbi.nlm.nih.gov

A brain-spine interface alleviating gait deficits after spinal cord injury in primates. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

A rodent brain-machine interface paradigm to study the impact of paraplegia on BMI performance. [2020]

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

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

6. England pubmed.ncbi.nlm.nih.gov

Training to use a commercial brain-computer interface as access technology: a case study. [2017]

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

A wearable neural interface for detecting and decoding attempted hand movements in a person with tetraplegia. [2020]

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

Advances in neuroprosthetic learning and control. [2021]

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

Brain-Computer Interface-FES Integration: Towards a Hands-free Neuroprosthesis Command System. [2022]

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

Brain-Computer Interfaces in Quadriplegic Patients. [2019]