GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Recruiting
N/A
Interventional Study
Tetraplegia/Tetraparesis
Quadriplegia
Quadriplegia/Tetraplegia
Cervical Spinal Cord Injury
Amyotrophic Lateral Sclerosis (ALS)
Spinal Cord Injury (Quadraplegia)
Spinal Cord Injury
Motor Neuron Disease
Brain Stem Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 7 (estimated)
- Sponsor
- Neuralink Corp · Industry
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About This Trial
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 br…
Trial Locations
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Eligibility Criteria
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 abil…
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