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Brain-Computer Interface

Brain-Computer Interface for Paralysis (PRIME Trial)

N/A
Recruiting
Led By Francisco Ponce, MD
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
History of poorly controlled seizures or epilepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new implant and robot device for people with tetraparesis or tetraplegia. The implant is placed on the skull and connected to electrodes in the brain by a robot

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risk from surgery, possible headaches or seizures related to brain implants, and unknown risks due to the novel nature of this technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had severe paralysis in all four limbs for at least a year without getting better.

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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I have a history of seizures or epilepsy 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 I was born with or developed.

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: Neuralink N1 Implant and R1 RobotExperimental Treatment2 Interventions
Implantation of the N1 Implant by the R1 Robot.

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Who is running the clinical trial?

Neuralink CorpLead Sponsor
2 Previous Clinical Trials
9 Total Patients Enrolled
2 Trials studying Quadriplegia
9 Patients Enrolled for Quadriplegia
Francisco Ponce, MDPrincipal InvestigatorBarrow Neurological Institute
~3 spots leftby Jan 2026
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