Seeking participants for the SWITCH Trial – Stentrode : A first in human device trial
An early feasibility study of the safety of the Stentrode™ 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.
The purpose of this research is to evaluate the safety of the Stentrode™ device in humans. This is an experimental device. 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 an area that controls movement (motor cortex). This does not involve open brain surgery.
This research will be the first of its kind to be performed in humans and may help us find safer, more effective ways to introduce/implant electrical sensors in patients' brains.
The total amount of time you could be in the study is approx. 3 years if you complete all parts of the study. There are two periods to the study, first the screening period (5 visits), and if you have been found suitable and undergo the procedure, there will be 10 clinical follow up visits over the 3-year period at The Royal Melbourne Hospital. Visits will be weekly for the first month, then monthly for the first 12 months, then yearly for years 2 and 3. There will also be technical visits 3 times a week for the first 12 months. At these visits you will learn how to use the device, and they can be conducted in your home, if you agree to this.
Anticipated date enrolment will close: 30 June 2021
Who can take part
The SWITCH Study might be right for you if you:
- are 18 to 75 years of age
- have a neurological condition where you have limited use of your arms and difficulty communicating
- are medically fit to undergo a procedure
- have somebody who can be a reliable study partner or caregiver and who can come to some study visits with you and answer questions about your health
What is involved for you
The study doctor will monitor your health by asking you and your study partner questions and doing various tests during the study. Some of these tests and assessments include;
- Physical and neurological examination
- Vital signs and ECGs
- Blood and urine tests
- Brain MRI
- CT scan of the vessels in your brain
- Tasks/tests using a computer