NCT06429735NARecruiting
Precise Robotically IMplanted Brain-Computer InterfacE
Neuralink Corp
Start Date
1/9/2024
Completion Date
1/1/2031
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 Criteria
Age Range: 22 years to 75 years
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
Interventions
DEVICE
N1 Implant
DEVICE
R1 Robot
Conditions
Tetraplegia/TetraparesisQuadriplegiaCervical Spinal Cord InjuryAmyotrophic Lateral SclerosisQuadriplegia/TetraplegiaTetraplegic; Paralysis
Locations
Barrow Neurological Institute
Phoenix, Arizona 85013
United States
University of Miami
Miami, Florida 33136
United States