COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis

Study Identifier:
S-02-01
ClinicalTrials.gov Identifier:
NCT05035823
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Synchron Medical, Inc.
Active, not recruiting

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Apr 2022 - Sep 2024
    Patient Requirements
    Sex: Female & Male
    Age: 21 - 75 Years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Severe quadriparesis
    • Able to give consent
    • Appropriate candidate for neurointerventional procedure
    • Able and willing to access all clinical testing and not impeded by geographical location
    • Proficient in English
    • Have a study partner
    Exclusion Criteria
    • Active condition resulting in immunosuppression
    • Unsuitable for general anesthesia
    • Anaphylactic allergy to contrast media
    • Allergy to nickel
    • History of pulmonary embolism
    • History of recent deep vein thrombosis
    • Psychiatric or psychological disorder
    • No study partner or caregiver
    • Unable to provide evidence of COVID vaccination

    Protocol Summary

    The Synchron motor neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.

    The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.

    Trial Locations

    Location
    Status
    Location
    University at Buffalo Neurosurgery (UBNS)
    Buffalo, New York, United States, 14203
    Status
    N/A
    Location
    Mount Sinai Health System
    New York, New York, United States, 10029
    Status
    N/A
    Location
    University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, United States, 15213
    Status
    N/A

    Contact Cure SMA

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