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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

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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