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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia


Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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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.

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Inclusion Criteria:
- Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy,
amyotrophic lateral sclerosis or other motor neuron disorders
- Complete or incomplete tetraplegia (quadriplegia)
- Must live within a three-hour drive of the Study site
- (There are additional inclusion criteria)
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)

Locations
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