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BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia

Study acronym: BrainGate2
StatusRecruiting
PhaseNot applicable
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 5 to 6v27
  2. Publications: details revised at 9 of 41 entriesv26
  3. Publications: details revised at 9 of 41 entriesv25
  4. Enrollment target: 22 to 27v24
  5. Re-verified, no change to tracked fieldsv23
Show 21 earlier versionsHide 21 earlier versions
  1. Enrollment target: 15 to 22
    • Publications: details revised at 1 of 41 entries
    v22
  2. 2 versions Re-verified since Dec 31, 2022, no change to tracked fieldsv20-v21
  3. Publications: 40 to 41v19
  4. Re-verified, no change to tracked fieldsv18
  5. Primary completion date: Sep 2026 to Sep 2038
    • Study sites: 4 to 5
    • Study completion date: Dec 2026 to Dec 2038
    v17
  6. Study sites: 3 to 4v16
  7. Re-verified, no change to tracked fieldsv15
  8. Primary completion date: Sep 2022 to Sep 2026v14 Show 4 more changesShow less
    • Study sites: 4 to 3
    • Study completion date: Dec 2022 to Dec 2026
    • Study description expanded, about 7 words
    • Publications: 27 to 40
  9. Site contacts updated at 1 of 4 sitesv13
  10. Primary completion date: Sep 2021 to Sep 2022v12 Show 4 more changesShow less
    • Study completion date: Dec 2021 to Dec 2022
    • Site contacts updated at 1 of 4 sites
    • Collaborators revised (3)
    • Publications: 22 to 27
  11. Site contacts updated at 1 of 4 sites
    • Collaborators: 5 to 3
    • Publications: 21 to 22
    v11
  12. Primary completion date: Sep 2018 to Sep 2021v10 Show 4 more changesShow less
    • Study completion date: Dec 2018 to Dec 2021
    • Interventions: Placement of the BrainGate2 sensor into the motor cortex (Device) to Placement of the BrainGate2 sensor(s) into the motor-related cortex (Device)
    • Site contacts updated at 1 of 4 sites
    • Collaborators: 4 to 5
  13. Collaborators revised (4)
    • Publications: 20 to 21
    • Study arms: 0 to 1
    v9
  14. Primary completion date: Sep 2017 to Sep 2018
    • Study completion date: Dec 2017 to Dec 2018
    • Publications: 15 to 20
    v8
  15. Primary completion date: Sep 2015 to Sep 2017
    • Study completion date: Dec 2015 to Dec 2017
    v7
  16. Study sites: 2 to 4
    • Collaborators: 3 to 4
    • Publications: 14 to 15
    v6
  17. Lead sponsor: Massachusetts General Hospital to Leigh R. Hochberg, MD, PhD.
    • Study sites: 1 to 2
    v5
  18. Eligibility criteria revised
    • Publications: 13 to 14
    v4
  19. Re-verified, no change to tracked fieldsv3
  20. Collaborators: 2 to 3v2
  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 NCT00912041
Lead Sponsor Leigh R. Hochberg, MD, PhD.
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), US Department of Veterans Affairs, National Institute of Neurological Disorders and Stroke (NINDS)
Conditions
(from sponsor)		 Tetraplegia, Spinal Cord Injuries, Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked in Syndrome, Muscular Dystrophy
Related terms Amyotrophic Lateral Sclerosis, Brain Stem Infarctions, Locked-In Syndrome, Muscular Dystrophies, Quadriplegia, Spinal Cord Injuries
Enrollment 27 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov