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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

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.


Condition or disease Intervention/treatment Phase
Neurologic Disorder Device: Motor Neuroprosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Single
Implantation of motor neuroprosthesis medical device.
Device: Motor Neuroprosthesis
Type of implantable brain computer interface




Primary Outcome Measures :
  1. Treatment related adverse events [ Time Frame: 12 months post implant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT05041114


Contacts
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Contact: Sue Dal Sasso +613 93427000 sue.dalsasso@mh.org.au

Locations
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Australia, Victoria
Melbourne Health
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Synchron Medical, Inc
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Responsible Party: Synchron Medical, Inc
ClinicalTrials.gov Identifier: NCT05041114    
Other Study ID Numbers: SWITCH II
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nervous System Diseases