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

Study acronym: BG-Speech-02
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor 2 versions Re-verified since Nov 27, 2024, no change to tracked fieldsv6-v7
  2. Minor Start date changed from estimate of Oct 2024 to Oct 16, 2023v5
  3. Minor Eligibility criteria shortened, about 26 wordsv4
  4. Minor Site details revisedv3
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT06094205
Lead Sponsor Leigh R. Hochberg, MD, PhD.
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions
(from sponsor)
Anarthria, Dysarthria, Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-in Syndrome, Muscular Dystrophies
Related terms Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Dysarthria, Locked-In Syndrome, Muscular Dystrophies, Quadriplegia, Spinal Cord Injuries
Enrollment 2 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov