Precise Robotically IMplanted Brain-Computer InterfacE

Recruiting N/A Interventional Study
Tetraplegia/Tetraparesis Quadriplegia Cervical Spinal Cord Injury Amyotrophic Lateral Sclerosis Quadriplegia/Tetraplegia Tetraplegic; Paralysis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
22 – 75
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
15 (estimated)
Sponsor
Neuralink Corp · Industry
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About This Trial
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 thr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 * Life expectancy ≥ 12 mont…
Contacts

Neuralink Clinical Team

(877) 398-4465

clinical-team-ct@neuralink.com

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