GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Recruiting now · Not applicable
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT07127172
- Run by
- Neuralink Corp
- People needed
- 7
- Starts
- 2025-07-31
- Expected to finish
- 2031-02-01
- Last updated by the study team
- 2025-08-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- (a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.
- OR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.
- 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
- 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
Where it is running
- University College London Hospitals NHS Foundation Trust — London, Greater London, United Kingdom (enrolling)
- The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, Tyne and Wear, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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