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.
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)
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)
Single group
Placement of the BrainGate2 sensor(s) into the motor-related cortex
DeviceUp 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.
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System.
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.
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Leigh R. Hochberg, MD, PhD.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
US Department of Veterans Affairs
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
