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

November 30, 2023 updated by: Synchron Medical, Inc.

Motor NeuroProsthesis to Restore Motor Control for the COMMAND of Digital Devices: An Early Feasibility Study (EFS) of Safety in Subjects With Severe Quadriparesis

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single
Implantation of the motor neuroprosthesis medical device.
Device: Motor Neuroprosthesis (MNP)
Type of implantable brain computer interface

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment-Related Serious Adverse Events
Time Frame: 12 months post implant
Number of subjects with treatment-related adverse events
12 months post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synchron Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 1, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-02-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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