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

Launched by LEIGH R. HOCHBERG, MD, PHD. · Oct 16, 2023

Keywords

ClinConnect Summary

The clinical trial titled "Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia" is designed to help people who have lost the ability to speak clearly due to conditions like spinal cord injuries, strokes, or muscular dystrophy. The main goal is to better understand how speech is produced and to develop a special device that allows individuals to communicate through a computer just by thinking about speaking. This could be a game-changer for those who struggle to express themselves verbally.

To participate in this study, you need to be between 18 and 80 years old and have a diagnosis related to conditions like tetraplegia or certain motor neuron disorders. You also need to live within a three-hour drive of the study site. If you are interested in joining, you can expect to engage in activities that help researchers learn how to improve the device while also having the chance to explore new ways of communication. It’s important to know that participants with certain visual impairments or serious health issues may not be eligible.

Gender

ALL

Eligibility criteria

• 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)