Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Launched by LEIGH R. HOCHBERG, MD, PHD. · Feb 1, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring a new technology called the BrainGate2 Neural Interface System, which aims to help people with tetraplegia—meaning they have limited movement and control of their limbs—control a computer cursor and other devices using their thoughts. This study is focusing on gathering information about the safety of this device and proving that it can work for individuals with conditions like amyotrophic lateral sclerosis (ALS) and other similar disorders that affect speech and movement.

To participate in this study, individuals need to be between 18 and 80 years old and have a confirmed diagnosis of ALS, particularly with difficulties in speaking. Participants should also live within a three-hour drive of the study site and have been stable in their condition for at least 15 months. During the trial, participants will have the chance to try out the device and provide feedback, which will help researchers understand how effective it is for controlling technology with thoughts. This trial is currently looking for volunteers, so if you or someone you know meets the eligibility criteria and is interested, it could be a valuable opportunity to contribute to this important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• 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)