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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

RecruitingNAAges 18 Years - 80 YearsAllLeigh R. Hochberg, MD, PhD.
NCT05724173 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Between 18 and 80 years of age. * Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases. * Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months. * Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. Exclusion Criteria: * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * Chronic oral or intravenous steroids or immunosuppressive therapy * Other serious disease or disorder that could seriously affect ability to participate in the study (There are additional exclusion criteria)
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What it tests

  • BrainGate Neural Interface System
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Where

2 sites
Stanford University School of Medicine
Stanford, United States
Massachusetts General Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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