Amyotrophic Lateral Sclerosis (ALS), Brain Stem Stroke, Cervical Spinal Cord Injury, Motor Neuron Disease, Quadriplegia, Quadriplegia/Tetraplegia, Spinal Cord Injury, Spinal Cord Injury (Quadraplegia), Tetraplegia/Tetraparesis
Conditions
Keywords
brain computer interface, Neuralink N1 Implant, Neuralink, Robot, tetraparesis, tetraplegia, quadriplegia, ALS, spinal cord injury, Amyotrophic lateral sclerosis, chip, brain chip, External device control, Wireless implant, Neuroprosthetics, SCI, paralysis, motor neuron disease
Brief 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.
Interventions
DEVICEN1 Implant
The N1 Implant is a type of implantable brain-computer interface.
DEVICER1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Sponsors
Newcastle-upon-Tyne Hospitals NHS Trust
University College London Hospitals
Neuralink Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The study is a pre UKCA/CE, prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Rate of Device-Related Adverse Events (AE) | 12 months post-implant |
| The Rate of Procedure-Related Adverse Events (AE) | 12 months post-implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study | From baseline to 3-, 6-, 9-, and 12-months post-implantation | The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit. |
| Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase | From baseline to 48-months post-implantation | The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit. |
| Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study | From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale used to assess depression severity. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Outcome will be reported as change from baseline at each follow-up visit. |
| The Rate of Procedure-Related Adverse Events (AE) | Up to 48 months post-implant | — |
| Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study | From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation | The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety severity. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Outcome will be reported as change from baseline at each follow-up visit. |
| Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase | From baseline to 48-months post-implantation | The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety severity. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Outcome will be reported as change from baseline at each follow-up visit. |
| Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase | From baseline to 48-months post-implantation | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale used to assess depression severity. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Outcome will be reported as change from baseline at each follow-up visit. |
| The Rate of Device-Related Adverse Events (AE) | Up to 48 months post-implant | — |
Countries
United Kingdom
Contacts
Primary ContactNeuralink Clinical Team
Outcome results
None listed