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History of Changes for Study: NCT05035823
COMMAND Trial S-02-01
Latest version (submitted April 22, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 1, 2021 None (earliest Version on record)
2 September 10, 2021 Study Identification, Contacts/Locations and Study Status
3 November 19, 2021 Study Status and Contacts/Locations
4 May 11, 2022 Recruitment Status, Study Status, Outcome Measures, Contacts/Locations, Eligibility, Conditions, Study Description and Oversight
5 August 1, 2022 Contacts/Locations, Study Status and Study Identification
6 August 29, 2022 Study Identification, Contacts/Locations and Study Status
7 December 7, 2022 Contacts/Locations and Study Status
8 March 19, 2023 Contacts/Locations and Study Status
9 April 13, 2023 Contacts/Locations and Study Status
10 November 30, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
11 April 22, 2024 Study Status
Comparison Format:
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Study NCT05035823
Submitted Date:  September 1, 2021 (v1)
Open or close this module Study Identification
Unique Protocol ID: S-02-01
Brief Title: COMMAND Trial S-02-01
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
Secondary IDs:
Open or close this module Study Status
Record Verification: September 2021
Overall Status: Not yet recruiting
Study Start: October 2021
Primary Completion: December 2024 [Anticipated]
Study Completion: June 2025 [Anticipated]
First Submitted: September 1, 2021
First Submitted that
Met QC Criteria:		 September 1, 2021
First Posted: September 5, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 September 1, 2021
Last Update Posted: September 5, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Synchron Medical, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
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 find out if the MMP device is safe in humans.

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 utilised for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.
Detailed Description:
Open or close this module Conditions
Conditions: Neurologic Disorder
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Device Feasibility
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 6 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Single
Implantation of the motor neuroprosthesis medical device.
 Device: Motor Neuroprosthesis (MNP)
Type of implantable brain computer interface
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Treatment-Related Adverse Events
[ Time Frame: 12 months post implant ]

Number of Participants With Treatment-Related Adverse Events
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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. Unable to provide evidence of COVID vaccination
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services