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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. )

Tracking Information
First Submitted Date  ICMJE September 1, 2021
First Posted Date  ICMJE September 5, 2021
Last Update Posted Date April 23, 2024
Actual Study Start Date  ICMJE April 27, 2022
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2022)		 Treatment-Related Serious Adverse Events [ Time Frame: 12 months post implant ]
Number of subjects with treatment-related adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2021)		 Treatment-Related Adverse Events [ Time Frame: 12 months post implant ]
Number of Participants With Treatment-Related Adverse Events
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Official Title  ICMJE Motor NeuroProsthesis to Restore Motor Control for the COMMAND of Digital Devices: An Early Feasibility Study (EFS) of Safety in Subjects With Severe Quadriparesis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • 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
Intervention  ICMJE Device: Motor Neuroprosthesis (MNP)
Type of implantable brain computer interface
Study Arms  ICMJE Single
Implantation of the motor neuroprosthesis medical device.
Intervention: Device: Motor Neuroprosthesis (MNP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 1, 2021)		 6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05035823
Other Study ID Numbers  ICMJE S-02-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Synchron, Inc. ( Synchron Medical, Inc. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Synchron Medical, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Synchron, Inc.
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP