Precise Robotically IMplanted Brain-Computer InterfacE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: N1 Implant, R1 Robot.
- Who it may be relevant to
- Registry conditions: Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis. Basic parameters: 22 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Overview
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.
Interventions
- Device N1 Implant
The N1 Implant is a type of implantable brain-computer interface - Device R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Primary outcome measures
- Device-Related Adverse Events (AE) [Time frame: 12 months post-implant]
- Procedure-Related Adverse Events (AE) [Time frame: 12 months post-implant]
Secondary outcome measures (2)
- Device-Related Adverse Events (AE) [Time frame: Up to 72 months post-implant]
- Procedure-Related Adverse Events (AE) [Time frame: Up to 72 months post-implant]
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 months.
- Ability to communicate in English
- Presence of a stable caregiver
Exclusion criteria
- Moderate to high risk for serious perioperative adverse events
- Active implanted devices
- Morbid obesity (Body Mass Index > 40)
- History of poorly controlled seizures or epilepsy
- History of poorly controlled diabetes
- Requires 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 demonstrating hemorrhage, tumor, distorted or adverse anatomy.
- Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 2 centers
- Barrow Neurological Institute — Phoenix
- University of Miami — Miami
Identifiers
NCT: NCT06429735 · N1-EFS-001