About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- BrainGate Neural Interface System
Treatment groups
Sponsors and collaborators
Leigh R. Hochberg, MD, PhD.
Lead sponsor
Massachusetts General Hospital
Sponsor institution
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator