Active not recruitingNAINTERVENTIONAL

Focused Ultrasound Stimulation of the Cerebellum to Induce Changes in Cognition and Brain Activity

This study is investigating a new way to gently stimulate a part of the brain called the cerebellum using focused ultrasound. Researchers want to see if this stimulation can change our thinking abilities, also known as cognition, and how our brain usually works. They are particularly interested in understanding if targeting different parts of the cerebellum (white or grey matter) with these sound waves causes different effects. This is a "preclinical" study, meaning it's an early-stage investigation, and it involves healthy volunteers between 18 and 40 years old. Participants will complete thinking tasks after receiving either active ultrasound stimulation or a dummy (sham) stimulation to compare the results. The overall goal is to learn more about how gentle sound waves might influence brain activity and thinking.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Nottingham

Enrolment target

Start

05 Feb 2024

Estimated completion

31 Jul 2026

Stroke Trauma Cognition Agency Verbal Memory CCAS

What is this study about?

This study is an early investigation looking at whether a special kind of sound wave, called focused ultrasound, can gently stimulate a part of the brain called the cerebellum. The cerebellum is important for things like movement and balance, but scientists are also learning that it might play a role in how we think and remember.

Researchers want to see if applying these sound waves to the cerebellum can change how our brain works and improve our thinking skills. They're also curious if it makes a difference whether the sound waves target certain parts of the cerebellum. By comparing active sound wave stimulation with a "sham" (dummy) stimulation, they can figure out if any changes they see are truly due to the sound waves.

This research is important because understanding how to gently influence brain activity could, in the future, open up new avenues for helping people with conditions that affect thinking and memory. For now, it's about learning more about the brain and how these sound waves interact with it in healthy people.

Key takeaways

Researches gentle sound waves on the brain (cerebellum).
Aims to understand effects on thinking and brain activity.
For healthy volunteers aged 18-40.
Compares active ultrasound to a dummy (sham) treatment.
No direct medical benefits expected for participants.
Participation involves thinking tasks after stimulation.

Who may be eligible?

This study is looking for healthy volunteers aged 18 to 40 years old. There are some important things that would mean you can't take part. For example, if you have any problems with enclosed spaces like MRI scanners, or if you're pregnant or planning to be, this study wouldn't be suitable.

Also, if you've ever had a neurological problem (like epilepsy or a stroke) or a mental health condition, or if you tend to faint easily, you wouldn't be able to join. You also can't have any medical devices implanted in your body, like a pacemaker.

It's important that your skin on or near your head is healthy. You also shouldn't be taking certain medications, especially those that affect your mind, and you'll need to avoid recreational drugs for two days before the study and limit alcohol for one day before.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 40 years old?
Do you feel comfortable in small, enclosed spaces?
Have you ever had a serious nerve or mental health condition?
Do you have any metal or electronic medical devices inside your body?
Are you currently pregnant or planning to be soon?
Do you typically avoid recreational drugs and limit alcohol?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either active focused ultrasound stimulation or a dummy (sham) stimulation to your cerebellum. This is done to help researchers compare the effects. After the stimulation, you would be asked to complete various tasks that test your thinking and memory. The tasks are designed to see if the stimulation has any effect on how your brain works and how you perform these activities. The study involves a few visits, and you would be told the exact number and length of these visits before you agree to take part. There is no medication involved beyond the potential use of ultrasound, and there is no long-term follow-up required after the planned study visits are complete. The total duration of your involvement will be clearly explained.

Potential risks and benefits

This is an early-stage study, so the main benefit is to contribute to scientific understanding of the brain and how focused ultrasound might affect it. There are no direct personal medical benefits expected for participants. Potential risks are generally low, as focused ultrasound is considered gentle. However, common side effects might include mild, temporary discomfort at the stimulation site. All potential risks will be thoroughly explained to you, and you will have the ability to withdraw from the study at any time without needing to give a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Precision Medical Imaging, QMC
Verified postcode
Nottingham, United Kingdom

Common questions

What is focused ultrasound?

It's a technology that uses gentle sound waves to precisely target a specific area inside the body, in this case, a part of the brain called the cerebellum.

What is the cerebellum?

It's a part of your brain that helps with movement and balance, and also plays a role in how you think and learn.

Will I feel sick or in pain during the ultrasound?

The stimulation is generally gentle, and any discomfort is expected to be mild and temporary. Researchers will monitor you closely.

Will I know if I'm getting the real or dummy treatment?

No, you won't know at the time. This is important for the study to fairly compare the effects without your expectations influencing the results.

How long will my involvement in the study last?

The total duration of your participation, including all visits, will be explained to you in detail before you agree to join.