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

Neuralink Corp

Status

Enrolling

Conditions

Motor Neuron Disease

Spinal Cord Injury (Quadraplegia)

Quadriplegia

Amyotrophic Lateral Sclerosis (ALS)

Brain Stem Stroke

Cervical Spinal Cord Injury

Tetraplegia/Tetraparesis

Spinal Cord Injury

Quadriplegia/Tetraplegia

Treatments

Device: R1 Robot

Device: N1 Implant

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07127172

354112 (Other Identifier)

N1-EFS-006

Details and patient eligibility

About

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.

Enrollment

7 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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