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

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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