Actively Recruiting
Precise Robotically IMplanted Brain-Computer InterfacE
Led by Neuralink Corp · Updated on 2026-01-09
15
Participants Needed
2
Research Sites
364 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Precise Robotically IMplanted Brain-Computer InterfacE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Severe quadriplegia (tetraplegia) from spinal cord injury or amyotrophic lateral sclerosis for at least 1 year without improvement
- Quadriplegia defined as having very limited or no hand, wrist, and arm movement and all levels below
- Life expectancy of at least 12 months
- Ability to communicate in English
- Presence of a stable caregiver
You will not qualify if you...
- Moderate to high risk for serious perioperative adverse events
- Presence of active implanted devices
- Morbid obesity (Body Mass Index over 40)
- History of poorly controlled seizures or epilepsy
- History of poorly controlled diabetes
- Need for magnetic resonance imaging (MRI) for any ongoing medical conditions
- Acquired or hereditary immunosuppression
- Use of smoking tobacco or other tobacco products
- Psychiatric or psychological disorder
- Brain MRI showing hemorrhage, tumor, distorted or adverse anatomy
- Any condition that would compromise safe participation or implantation procedure as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
N
Neuralink Clinical Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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