What is Low-Intensity Focused Ultrasound (LIFU)?
Low-Intensity Focused Ultrasound (LIFU) is a type of Transcranial Ultrasound Stimulation (TUS) that is a new, safe, and non-invasive way to change brain activity. LIFU stimulates the brain using low-intensity sound waves to temporarily change brain activity in a person. LIFU can target structures deep in the brain to deliver precise ultrasonic energy withough causing damage to the surrounding tissues.
Is LIFU safe?
LIFU brain stimulation is non-invasive and has been shown to be safe in both human and animal studies. The BrainBox NeuroFus LIFU device has been used safely in prior published human research studies involving over a hundred subjects. This device is not regulated by the Food and Drug Administration (FDA) and is for research use only.
All LIFU brain stimulation proposed in this study will conform to the safety guidelines of the International Consortium for Transcranial Ultrasonic Stimulation Safety and Standards (ITRUSST) which are based on existing guidelines for diagnostic ultrasound (used widely for fetal/prenatal imaging, imaging of the gallbladder or kidney, and imaging of the heart) from regulatory bodies including the FDA, the British Medical Ultrasound Society (BMUS) and the American Institute of Ultrasound in Medicine (AIUM).
What will happen during the LIFU stimulation procedure?
For the LIFU stimulation procedure you will be seated in a comfortable chair. A device called a ‘neuronavigation system’ will use cameras together with information from your brain MRI to predict exactly where the ultrasound stimulation will occur in your brain. To do this the device first needs to be calibrated or ‘registered’ to some points on your head and to the ultrasound device.
The device that emits the ultrasound waves is called the LIFU transducer and resembles a small hockey puck with a curved surface and attached cable. The transducer will be held next to your scalp by a positioning device. The position of the transducer will be adjusted using information from the neuronavigation system so that the ultrasound waves target the correct part of your brain. Some ultrasound gel will be applied to your scalp to improve the transmission of the ultrasound waves between the transducer and your scalp.
What does LIFU feel like?
While the LIFU stimulation is happening you may hear a faint buzzing or pulsing sound. Some people also report experiencing a mild tingling sensation or mild sensation of warmth in their scalp beneath the LIFU transducer, other people do not report experiencing anything.
What device will be used?
This study will utilize the BrainBox NeuroFUS Pro device.
How does transcranial-focused ultrasound work?