RecruitingNot ApplicableNCT06429735

Precise Robotically IMplanted Brain-Computer InterfacE

PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Sponsor

Neuralink Corp

Enrollment

15 participants

Start Date

Jan 9, 2024

Study Type

INTERVENTIONAL

Conditions

Quadriplegia Amyotrophic Lateral Sclerosis Cervical Spinal Cord Injury Tetraplegia/Tetraparesis Quadriplegia/Tetraplegia Tetraplegic; Paralysis

Summary

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.

Eligibility

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called N1 Implant and a medical device called R1 Robot for people with amyotrophic lateral sclerosis, cervical spinal cord injury, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 22 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEN1 Implant

The N1 Implant is a type of implantable brain-computer interface

DEVICER1 Robot

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Locations(2)

Barrow Neurological Institute

Phoenix, Arizona, United States

University of Miami

Miami, Florida, United States

View Full Details on ClinicalTrials.gov

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NCT06429735

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