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

Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface

Who can join

Ages 18 to 80 · All sexes

Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

About the study

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.

What is being tested

• BrainGate Neural Interface System (device)

Sponsor: Leigh R. Hochberg, MD, PhD. · Participants: 2 · Started: Oct 16, 2023

Contact the study team

• Leigh R. Hochberg, M.D., Ph.D. · Phone: 617-724-9247
• Sergey Stavisky, Ph.D. · Phone: 530-754-3413

Official record on ClinicalTrials.gov — NCT06094205

Locations in the U.S.

Conditions

• Dysarthria
• Quadriplegia
• Spinal Cord Injuries
• Amyotrophic Lateral Sclerosis
• Brain Stem Infarctions
• Muscular Dystrophy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.