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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Implantation of motor neuroprosthesis medical device.
Device: Motor Neuroprosthesis
Type of implantable brain computer interface
- Treatment related adverse events [ Time Frame: 12 months post implant ]
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
|Contact: Sue Dal Sasso||+613 firstname.lastname@example.org|
|Melbourne, Victoria, Australia, 3050|