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

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

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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