Trials / Recruiting
RecruitingNCT07127172
GB-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
- 7 (estimated)
- Sponsor
- Neuralink Corp · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions. The N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.
Conditions
- Tetraplegia/Tetraparesis
- Quadriplegia
- Quadriplegia/Tetraplegia
- Cervical Spinal Cord Injury
- Amyotrophic Lateral Sclerosis (ALS)
- Spinal Cord Injury (Quadraplegia)
- Spinal Cord Injury
- Motor Neuron Disease
- Brain Stem Stroke
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
- 2025-07-31
- Primary completion
- 2028-01-01
- Completion
- 2031-02-01
- First posted
- 2025-08-17
- Last updated
- 2025-08-17
Locations
2 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT07127172. Inclusion in this directory is not an endorsement.