Trials / Recruiting
RecruitingNCT06429735
Precise Robotically IMplanted Brain-Computer InterfacE
PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Neuralink Corp · Industry
- Sex
- All
- Age
- 22 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Tetraplegia/Tetraparesis
- Quadriplegia
- Cervical Spinal Cord Injury
- Amyotrophic Lateral Sclerosis
- Quadriplegia/Tetraplegia
- Tetraplegic; Paralysis
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-01-09
- Primary completion
- 2026-06-01
- Completion
- 2031-01-01
- First posted
- 2024-05-28
- Last updated
- 2026-01-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06429735. Inclusion in this directory is not an endorsement.