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Brain-Computer Interface

Neuralink Brain-Computer Interface for Quadriplegia (CAN-PRIME Trial)

N/A
Recruiting
Research Sponsored by Neuralink Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
Be older than 18 years old
Must not have
History of poorly controlled diabetes
Morbid obesity (Body Mass Index > 40)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of Neuralink's N1 Implant and R1 Robot in individuals with limited movement in their arms and legs. The N1 Implant is a small

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects aren't detailed here but may include risks associated with surgical procedures such as infection, bleeding, or damage to surrounding tissues; device-specific issues like malfunction; and neurological effects from brain interfacing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had severe quadriplegia for at least a year without improvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of diabetes that is hard to control.
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My BMI is over 40.
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I have a weakened immune system, either from a condition or inherited.
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I have a history of seizures or epilepsy that is hard to control.
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My brain MRI shows bleeding, tumor, or abnormal structure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CAN-PRIME: Precise Robotically Implanted Brain-Computer InterfaceExperimental Treatment2 Interventions
Open label

Find a Location

Who is running the clinical trial?

University Health Network, TorontoOTHER
1,531 Previous Clinical Trials
504,316 Total Patients Enrolled
Neuralink CorpLead Sponsor
2 Previous Clinical Trials
8 Total Patients Enrolled
~4 spots leftby Nov 2027
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