The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with aphasia to generate text on a computer screen and audible, computer-generated speech by attempting to speak.
Clinical diagnosis of expressive aphasia due to ischemic or hemorrhagic stroke (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
BrainGate Neural Interface System
DeviceUp to six 4x4 mm BrainGate sensor(s) are placed into the speech or language-related cortex, connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.
Safety of the BrainGate2 Neural Interface System
The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System
Feasibility of speech decoding
The secondary endpoints of this Study are to investigate the feasibility of the BrainGate system and to establish the parameters for a larger clinical study, The main secondary endpoint is the ability of the system to decode neural signals related to speech / language generation into output for text- and/or speech- generating devices.
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Leigh R. Hochberg, MD, PhD.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
