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

Recruiting now · Not applicable

Conditions studied: Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-in Syndrome, Muscular Dystrophies

In brief

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.

Key facts

Study ID

NCT06094205

Run by

Leigh R. Hochberg, MD, PhD.

People needed

2

Starts

2023-10-16

Expected to finish

2027-08-31

Last updated by the study team

2025-12-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• (There are additional inclusion criteria)

You may not qualify if…

• 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)

Where it is running

• University of California, Davis — Sacramento, California, United States (enrolling)

Full record on ClinicalTrials.gov

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