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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
27
Up to six 4x4 mm BrainGate2 sensor(s) are placed into the motor-related cortex (including speech-related areas of cortex), connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
University of California, Davis
Sacramento, California, United States
RECRUITINGStanford University School of Medicine
Stanford, California, United States
RECRUITINGEmory University School of Medicine
Atlanta, Georgia, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGProvidence VA Medical Center
Providence, Rhode Island, United States
RECRUITINGThe primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.
Time frame: One year post-implant evaluation period
To investigate the feasibility of BrainGate2 and to establish the parameters for a larger clinical study, such as appropriate neural decoding algorithms, sample size, indices of measurement, success criteria, and endpoints.
Time frame: Course of the study
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