RecruitingTetraplegia/TetraparesisQuadriplegiaCervical Spinal Cord Injury
Precise Robotically IMplanted Brain-Computer InterfacE
Eligible age
22–75 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Neuralink Corp
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT06429735 · last updated 2026-01-09