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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05035823
Recruitment Status : Active, not recruiting
First Posted : September 5, 2021
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Synchron, Inc. ( Synchron Medical, Inc. )

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Neurologic Disorder Paralysis Paralysis; Stroke Amyotrophic Lateral Sclerosis Muscular Dystrophies Spinal Cord Injuries Stroke, Lacunar Stroke Brainstem Cervical Spinal Cord Injury Spinal Muscular Atrophy Tetraplegic; Paralysis Quadriplegia/Tetraplegia Device: Motor Neuroprosthesis (MNP) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Motor NeuroProsthesis to Restore Motor Control for the COMMAND of Digital Devices: An Early Feasibility Study (EFS) of Safety in Subjects With Severe Quadriparesis
Actual Study Start Date : April 27, 2022
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Single
Implantation of the motor neuroprosthesis medical device.
 Device: Motor Neuroprosthesis (MNP)
Type of implantable brain computer interface


Outcome Measures
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Primary Outcome Measures :
  1. Treatment-Related Serious Adverse Events [ Time Frame: 12 months post implant ]
    Number of subjects with treatment-related adverse events


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Severe quadriparesis
  2. Able to give consent
  3. Appropriate candidate for neurointerventional procedure
  4. Able and willing to access all clinical testing and not impeded by geographical location
  5. Proficient in English
  6. Have a study partner

Exclusion Criteria:

  1. Active condition resulting in immunosuppression
  2. Unsuitable for general anesthesia
  3. Anaphylactic allergy to contrast media
  4. Allergy to nickel
  5. History of pulmonary embolism
  6. History of recent deep vein thrombosis
  7. Psychiatric or psychological disorder
  8. No study partner or caregiver
  9. Unable to provide evidence of COVID vaccination
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05035823


Locations
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United States, New York
University at Buffalo Neurosurgery (UBNS)
Buffalo, New York, United States, 14203
Mount Sinai Health System
New York, New York, United States, 10029
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Synchron Medical, Inc.
More Information
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Responsible Party: Synchron Medical, Inc.
ClinicalTrials.gov Identifier: NCT05035823    
Other Study ID Numbers: S-02-01
First Posted: September 5, 2021    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Muscular Dystrophies
Stroke
Spinal Cord Injuries
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Muscular Atrophy
Muscular Atrophy, Spinal
Paralysis
Quadriplegia
Nervous System Diseases
Stroke, Lacunar
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Spinal Cord Diseases
Trauma, Nervous System
Atrophy
Pathological Conditions, Anatomical
Neurodegenerative Diseases
Neuromuscular Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases