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Recruiting NCT06094205

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

Trial Parameters

Condition Anarthria
Sponsor Leigh R. Hochberg, MD, PhD.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 2
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-10-16
Completion 2027-08-31
Interventions
BrainGate Neural Interface System

Brief Summary

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.

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)

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