The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.
Between 18 and 80 years of age
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 and geographically stable for at least 15 months after enrollment.
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
Single group
BrainGate Neural Interface System
DevicePlacement of the BrainGate2 sensor(s) into the speech-related cortex
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and: 1. the sensors are not explanted for safety reasons during the one-year post-implant evaluation period. 2. there are no device-related Serious Adverse Events that result in death or permanently increased disability during the one-year post-implant evaluation period.
Decoded speech output accuracy
The purpose of this feasibility measure is to define the metrics by which a larger trial of intracortical recording for the restoration of speech-based communication might be planned. The secondary endpoints are: * The word error rate of speech that is output by the System * The phoneme error rate of speech that is output by the System
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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
