What is the UltraThera device?
In this study, we are testing a new ultrasound device called UltraThera, which was developed at UQ's Queensland Brain Institute. Using the device, the study team will administer ultrasound energy to the brain, producing an effect known as neuromodulation.
Although this study is the first time that the UltraThera device is being used in people, very similar types of technology have already been used in other human clinical trials without causing major side effects.
The UltraThera device has also been designed and developed in accordance with international medical device standards.
What is neuromodulation?
The Queensland Brain Institute team developed this potential new treatment because they found that by delivering a specific form of ultrasound energy into the brain, they can produce an effect known as neuromodulation.
Neuromodulation is the alteration or modulation of nerve activity and overall brain function. Ultrasound neuromodulation has been shown to enhance the communication between brain cells in preclinical mouse studies and to improve memory. It is hoped that in people, this may also have therapeutic effects, improving some of the symptoms of Alzheimer's disease.
What is involved in the Scanning Ultrasound Study?
This study is the first time that the UltraThera device will be used on people. The study aims to collect safety data on the device.
As we are checking whether the device is safe, we are only testing the device on 12 people. The study team plan to conduct additional studies using the device if it is deemed safe for use on people.
The study consists of four ultrasound treatments, which are done face-to-face in Brisbane, Queensland every two weeks. The treatment will occur at Mater Hospital.
Participants will be required to shave their heads to have the therapy. After completing the course of treatments, the participants will have an MRI scan of the brain at The University of Queensland in St Lucia, Brisbane. The study doctors and nurses will also ask you to complete questionnaires before, during and after the study.
Your participation in the study will last for between seven and 15 weeks. After the study, your normal healthcare team and neurologist will follow up with you.
Once all participants have completed the trial, researchers will analyse the outcomes. The study is predicted to take about one year to complete, and the results will be published after this time.