Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)

Launched by LEIGH R. HOCHBERG, MD, PHD. · Jul 16, 2024

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ClinConnect Summary

This clinical trial, called the BrainGate2 Neural Interface System study, is looking at how to help people with conditions like brainstem stroke, advanced ALS, and spinal cord injuries communicate better using tablets. Many of these individuals are awake and aware but cannot move or speak. The goal of the study is to develop a special device that can read brain signals and allow these patients to use communication apps on tablets quickly and easily.

To be eligible for this study, participants must have a diagnosis of a spinal cord injury, brainstem stroke, or other similar conditions that cause complete or partial paralysis. They should also live within a three-hour drive from the study site and have previously participated in the BrainGate2 clinical trial. Participants can expect to take part in activities that might help improve their ability to communicate using technology. It's important to note that certain health issues, like severe vision problems or serious diseases, may prevent someone from joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• • Prior enrollment in BrainGate2 clinical trial (NCT00912041)
• 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)