Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLeigh R. Hochberg, MD, PhD.

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

3 Participants
are divided into 1 treatment group

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