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.
Between 18 and 80 years of age.
Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.
Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.
Must be 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
Device Safety
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.
Device Feasibility
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: Number of participants that are able to use the BrainGate system to communicate via speech decoding: 1. at a rate of at least 5 words per minute and 2. with less than a median word error rate of 50%.
Click on the lead sponsor to view all of their trials.
Leigh R. Hochberg, MD, PhD.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
