GB-PRIME is a multi-site feasibility study that aims to evaluate the safety and functionality of Neuralink’s N1 Implant. It is a fully implantable, intracortical BCI designed to help individuals with severe neurological conditions, such as spinal cord injury and Motor Neurone Disease, to control devices and communicate more independently with their thoughts. The N1 Implant records brain signals through over 1,000 electrodes distributed across ultra-thin threads, which are each finer than a human hair and precisely placed within microns of targeted neurons by Neuralink’s purpose-built R1 Robot.
This follows from Neuralink’s clinical trials in the United States, where several patients have been implanted with the N1 Implant and are using it to control useful devices in their daily lives, such as computers, smartphones, and robotic arms.
The launch of GB-PRIME at UCLH marks an important step towards advancing BCI technology that has the potential to transform the lives of individuals with neurological disorders around the world.
The Chief Investigator for the study, Prof Harith Akram, UCLH consultant neurosurgeon at the National Hospital for Neurology and Associate Professor at the UCL Queen Square Institute of Neurology, said:
“The launch of GB-PRIME at UCLH represents a major milestone in the development of brain-computer interface technology, with the potential to transform the lives of people living with severe neurological disorders worldwide.”
The Principal Investigator at UCLH, Mr William Muirhead, consultant neurosurgeon at the National Hospital for Neurology, and Honorary Senior Research Fellow at the UCL Queen Square Institute of Neurology, said:
“This study reflects our commitment to pioneering therapies that restore function, independence, and communication in patients with profound neurological disability. UCLH is proud to be at the forefront of this field, bringing together clinical excellence and cutting-edge neuroscience to deliver meaningful innovation in patient care.”
The study will involve up to 7 participants in Great Britain who cannot walk and whose manual control of a computer, smartphone, or tablet is significantly impaired or impossible because of their severe neurological condition.
Patients enrolled by UCLH will undergo their surgery at UCLH’s National Hospital for Neurology and Neurosurgery at Queen Square. The study will be managed at the Leonard Wolfson Experimental Neurology Centre, which is part of the NIHR UCLH Clinical Research Facility and the study is being supported by NIHR UCLH Biomedical Research Centre infrastructure including the UCLH and UCL Joint Research Office.
Individuals interested in participating in GB-PRIME are invited to learn more about the study and join Neuralink’s Patient Registry at neuralink.com/trials
Note: The N1 Implant and R1 Robot are investigational medical devices that have been approved for use in this research study by the Medicines and Healthcare products Regulatory Agency (MHRA), the Health Research Authority (HRA) and Health and Care Research Wales (HCRW), and the London – Camberwell St Giles Research Ethics Committee (REC). At this time, the GB-PRIME study will not include the use of BCI for robotic arm control.
Source: NIHR UCLH Biomedical Research Centre