Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)

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

About this trial

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.

Eligibility criteria

Qualifiers

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.

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

2 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