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STENTRODE™ WITH THOUGHT CONTROLLED DIGITAL SWITCH: An Early Feasibility Study (EFS) of the Safety of an Endovascular Motor NeuroProsthesis (MNP) Device in Participants With Severe Upper Limb Impairment. (SWITCH)

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ClinicalTrials.gov Identifier: NCT05041114
Recruitment Status : Not yet recruiting
First Posted : September 10, 2021
Last Update Posted : September 10, 2021
Sponsor:
Information provided by (Responsible Party):
Synchron Medical, Inc

Tracking Information
First Submitted Date  ICMJE September 1, 2021
First Posted Date  ICMJE September 10, 2021
Last Update Posted Date September 10, 2021
Estimated Study Start Date  ICMJE October 2021
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 2, 2021)
Treatment related adverse events [ Time Frame: 12 months post implant ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 STENTRODE™ WITH THOUGHT CONTROLLED DIGITAL SWITCH: An Early Feasibility Study (EFS) of the Safety of an Endovascular Motor NeuroProsthesis (MNP) Device in Participants With Severe Upper Limb Impairment.
Official Title  ICMJE STENTRODE™ WITH THOUGHT CONTROLLED DIGITAL SWITCH: An Early Feasibility Study (EFS) of the Safety of an Endovascular Motor NeuroProsthesis (MNP) Device in Participants With Severe Upper Limb Impairment.
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 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: Treatment
Condition  ICMJE Neurologic Disorder
Intervention  ICMJE Device: Motor Neuroprosthesis
Type of implantable brain computer interface
Study Arms  ICMJE Single
Implantation of motor neuroprosthesis medical device.
Intervention: Device: Motor Neuroprosthesis
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 2, 2021)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Severe motor impairment
  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 anaesthetic
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sue Dal Sasso +613 93427000 sue.dalsasso@mh.org.au
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05041114
Other Study ID Numbers  ICMJE SWITCH II
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: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Synchron Medical, Inc
Study Sponsor  ICMJE Synchron Medical, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Synchron Medical, Inc
Verification Date September 2021

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