At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- N1 Implant (device), R1 Robot (device)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- N1 Implant — device: The N1 Implant is a type of implantable brain-computer interface. · R1 Robot — device: The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 7
- Started
- 2025-07-31
- Last checked
- 2025-07
Plain English Summary
What is this study?
- • Testing a new treatment for tetraplegia/tetraparesis
- • NA - 7 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with tetraplegia/tetraparesis
Where?
- • London - University College London Hospitals NHS Foundation Trust
- • Newcastle upon Tyne - The Newcastle upon Tyne Hospitals NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Life expectancy ≥ 12 months.
- ✓Ability to communicate in English
- ✓Presence of a stable caregiver
Who cannot take part
- ✗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
See the full criteria
Where Is This Study? (2 UK sites)
University College London Hospitals NHS Foundation Trust
London WC1N 3BG, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne NE2 4HH, United Kingdom
How to Get in Touch
Neuralink Clinical Team
Sponsor contactCONTACT
