SWITCH Study
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
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
Implantation of Stentrode device
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Treatment-Related Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 12 month post implant
High fidelity and stable signals over 12 months
1. 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 2. The mean and SD of noise floor calculated from 2 mins of baseline recording 3. The mean and SD of signal-to-noise ratio across 3 mins recording of photic stimulation
Time frame: 36 months
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