Amyotrophic Lateral Sclerosis, Cervical Spinal Cord Injury, Quadriplegia, Quadriplegia/Tetraplegia, Tetraplegia/Tetraparesis, Tetraplegic; Paralysis
Conditions
Keywords
spinal cord injury, SCI, BCI, brain computer interface, ALS, quadriplegia, tetraplegic, paralysis
Brief 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.
Interventions
DEVICEN1 Implant
The N1 Implant is a type of implantable brain-computer interface
DEVICER1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Sponsors
Neuralink Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device-Related Adverse Events (AE) | 12 months post-implant |
| Procedure-Related Adverse Events (AE) | 12 months post-implant |
Secondary
| Measure | Time frame |
|---|---|
| Device-Related Adverse Events (AE) | Up to 72 months post-implant |
| Procedure-Related Adverse Events (AE) | Up to 72 months post-implant |
Countries
United States
Contacts
Primary ContactNeuralink Clinical Team
Outcome results
None listed