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Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Study acronym: BG-Speech-01
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Jul 2026 to Jul 31, 2027
    • Study completion date: Dec 2026 to Jul 31, 2027
    v11
  2. Enrollment target: 2 to 3v10
  3. Re-verified, no change to tracked fieldsv9
  4. Eligibility criteria shortened, about 16 wordsv8
  5. Start date changed from estimate of Oct 1, 2023 to Oct 18, 2023v7
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  1. Start date: Aug 1, 2023 to Oct 1, 2023v6
  2. Eligibility criteria revisedv5
  3. Start date: Mar 21, 2023 to Aug 1, 2023v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2023 to Mar 21, 2023
    v3
  5. Primary completion date: Jul 31, 2026 to Jul 2026
    • Study completion date: Dec 31, 2038 to Dec 2026
    • Start date: Feb 1, 2023 to Mar 2023
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Leigh R. Hochberg, MD, PhD.
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The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
Trial Details
NCT Number NCT05724173
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 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov