GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Neuralink Corp7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Tetraplegia/Tetraparesis Quadriplegia Quadriplegia/Tetraplegia Cervical Spinal Cord Injury Amyotrophic Lateral Sclerosis (ALS)

Interventions

N1 ImplantDEVICE

The N1 Implant is a type of implantable brain-computer interface.

R1 RobotDEVICE

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University College London Hospitals NHS Foundation Trust

London, Greater London, United Kingdom

RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne and Wear, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

The Rate of Device-Related Adverse Events (AE)

Time frame: 12 months post-implant

The Rate of Procedure-Related Adverse Events (AE)

Time frame: 12 months post-implant

Secondary Outcomes

The Rate of Device-Related Adverse Events (AE)

Time frame: Up to 48 months post-implant

The Rate of Procedure-Related Adverse Events (AE)

Time frame: Up to 48 months post-implant

Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study

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.

Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation

Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase

Time frame: From baseline to 48-months post-implantation

Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study

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.

Time frame: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation

Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase

Time frame: From baseline to 48-months post-implantation

Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study

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.

Time frame: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation

Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase

Time frame: From baseline to 48-months post-implantation

GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts