SWITCH: Stentrode First-in-Human Study of Implantable BCI for Control of a Digital Device
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|ClinicalTrials.gov Identifier: NCT03834857|
Recruitment Status : Completed
First Posted : February 8, 2019
Last Update Posted : September 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Neurologic Disorder||Device: Stentrode||Not Applicable|
STENTRODE WITH THOUGHT CONTROLLED DIGITAL SWITCH: An early feasibility study (EFS) of the safety of the StentrodeTM device in participants with loss of motor function due to paralysis from spinal cord injury, motor neuron disease, stroke, muscular dystrophy or loss of limbs.
Research has shown that in individuals with neurological conditions, brain signals can be recorded using electrical sensors implanted on to the brain. These signals could be used by the individuals to control assistive technology (e.g. spelling devices) that help with daily life, just by thinking. However, implanting these electrical sensors often requires open brain surgery.
A new medical device and surgical technique has been developed, which allows implantation of the electrical sensors without open brain surgery. The device, called Stentrode™, is a small metallic mesh tube (stent), with electrode contacts (small metal disks) within the stent structure. It can be placed inside a blood vessel of the brain located in the motor cortex. This does not involve open brain surgery.
The purpose of this research is to evaluate the safety of the Stentrode™ device in humans. This is an experimental device. This research will be the first of its kind to be performed in humans and may help find safer, more effective ways to introduce/implant electrical sensors in patients. This could foster the development of user friendly biotechnology for patients with neurological conditions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Insertion of Stentrode TM device|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study (EFS) of the Safety of the Stentrode Device in Participants With Loss of Motor Function Due to Paralysis|
|Actual Study Start Date :||May 27, 2019|
|Actual Primary Completion Date :||December 10, 2021|
|Actual Study Completion Date :||January 9, 2022|
Implantation of Stentrode device
Implantation of Stentrode device
- Treatment-Related Adverse Events [ Time Frame: 12 month post implant ]Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- High fidelity and stable signals over 12 months [ Time Frame: 36 months ]
- The mean and standard deviation (SD) of first three measurements of impedance values across all 16 channels, excluding flag values, to a maximum of 10 measurements
- The mean and SD of noise floor calculated from 2 mins of baseline recording
- The mean and SD of signal-to-noise ratio across 3 mins recording of photic stimulation
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): NCT03834857
|Royal Melbourne Hospital|
|Melbourne, Victoria, Australia, 3050|
|Study Director:||Thomas Oxley||University of Melbourne and Synchron|