GB-PRIME
Research type
Research Study
Full title
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices\n
IRAS ID
354112
Contact name
Neuralink Clinical Team
Contact email
Sponsor organisation
Neuralink Corp.
Duration of Study in the UK
4 years, 6 months, 0 days
Research summary
For individuals with paralysis, improving self-efficacy, independence and quality of life can be transformative. Brain Computer Interfaces (BCI) have the potential to restore functional capabilities for individuals with tetraplegia and tetraparesis by enabling the control of external devices using only thoughts. \n\nThis study is a prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study aiming to evaluate the initial clinical safety and device functionality of Neuralink’s N1 System and R1 System. The N1 System includes the N1 Implant, which is a wireless and rechargeable implant connected to 128 flexible electrode threads. The R1 System includes the R1 Robot, which is a surgical robot that assists the neurosurgeon by inserting the N1 Implant threads into the brain. Once implanted, the N1 Implant measures neuronal signalling in the motor cortex and uses the decoded signals to wirelessly control external devices such as a computer cursor or virtual keyboard. \n\nThis study aims to recruit up to 7 participants with tetraparesis (quadriparesis) or tetraplegia (quadriplegia), or a diagnosis with a progressive course towards tetraparesis or tetraplegia, including individuals diagnosed with spinal cord injury, brain stem stroke, Motor Neurone Disease (MND), and Amyotrophic Lateral Sclerosis (ALS). Participants must be 18 years of age or older. The study intends to recruit participants at two NHS hospital sites in England. \n\nThe study consists of a 12-month primary study and 36 months of long-term follow-up. Study procedures involve two surgeries: an implantation surgery to implant the N1 Implant into the brain, and an explantation procedure (elective) to remove the N1 Implant. Participants will also take part in BCI research sessions every week to assess the performance of the N1 Implant, and will also be able to use their BCI independently from any location, including their home. \n\nThe study is funded by the sponsor, Neuralink Corp
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
25/LO/0189
Date of REC Opinion
28 Mar 2025
REC opinion
Favourable Opinion