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RecruitingNot ApplicableNCT06094205

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

Sponsor

Leigh R. Hochberg, MD, PhD.

Enrollment

2 participants

Start Date

Oct 16, 2023

Study Type

INTERVENTIONAL

Conditions

AnarthriaAmyotrophic Lateral SclerosisSpinal Cord InjuriesDysarthrialocked-in SyndromeMuscular DystrophiesBrain Stem Infarctionstetraplegia

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria3

  • 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

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Interventions

DEVICEBrainGate Neural Interface System

Placement of the BrainGate2 sensor(s) into the speech-related cortex

Locations(1)

University of California, Davis

Sacramento, California, United States

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NCT06094205

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