RecruitingNAINTERVENTIONAL

Intermittent Theta-Burst Stimulation to Improve Negative Symptoms and Cognition in Schizophrenia

This research study aims to find out if a special type of brain stimulation, called intermittent theta-burst stimulation (iTBS), can help people with schizophrenia. Specifically, it wants to see if iTBS can improve what are known as "negative symptoms" – things like having very little motivation, expressing less emotion, or finding it hard to enjoy activities. It also hopes to see if iTBS can help with thinking and memory problems. The study involves stimulating specific areas of the brain and comparing this active treatment to a 'sham' (dummy) stimulation, where participants go through the motions but don't receive the actual treatment. This helps researchers understand if any improvements are truly due to the iTBS.

At a glance

Status

Recruiting

Phase

Sponsor

Hannover Medical School

Enrolment target

Start

08 Apr 2025

Estimated completion

31 Dec 2026

Schizophrenia Patients

What is this study about?

This study is investigating a new way to help people with schizophrenia who experience certain difficulties. These are often called 'negative symptoms' – meaning things that are missing or reduced, like having less energy, less interest in social activities, or difficulty showing emotions. The study also aims to improve 'thinking skills,' which can include memory, attention, and problem-solving.

The treatment being tested is called intermittent theta-burst stimulation, or iTBS for short. It's a non-invasive procedure, meaning it doesn't involve surgery. It uses magnetic pulses to gently stimulate specific areas of the brain: one area involved in movement and coordination (called the cerebellar vermis) and another important for planning and decision-making (the left dorsolateral prefrontal cortex). Researchers want to see if stimulating these areas can make a positive difference.

To find out if iTBS truly helps, some participants will receive the active iTBS treatment, while others will receive a 'sham' or dummy treatment. This sham treatment feels similar to the real one but doesn't actually deliver the magnetic pulses, which helps ensure that any improvements seen are really due to the iTBS and not just the expectation of feeling better. All participants and the research team won't know who is receiving which treatment until the study is over, making the results more reliable.

Key takeaways

This study tests a new brain stimulation for schizophrenia.
It aims to improve low motivation, reduced emotions, and thinking skills.
Participants will receive 10 sessions over two weeks.
Some will get active treatment, others a dummy treatment (blinded).
Extensive checks will happen before, immediately after, and weeks later.
It could help us understand brain function in schizophrenia better.

Who may be eligible?

This study is looking for adults aged between 18 and 65 years old who have been diagnosed with schizophrenia. You must be able to understand the study and agree to take part.

There are several reasons why you might not be able to join. For example, if you have any electronic or certain metal implants in your body (like a pacemaker, cochlear implant, or even some metal fragments), as these could be affected by the stimulation or MRI scans. You also can't take part if you have claustrophobia, active epilepsy, or have had a recent head injury, stroke, or brain infection.

Other reasons include being pregnant, currently misusing drugs or alcohol, or planning to change your psychiatric medication in the next two weeks. If you have serious physical illnesses that could make the examinations difficult or unsafe, you also might not be able to participate.

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.

I am between 18 and 65 years old.
I have a diagnosis of schizophrenia.
I do not have a pacemaker or other electronic implant.
I am not pregnant.
I haven't had a recent head injury, stroke, or brain infection (within 3 months).
I am not currently misusing drugs or alcohol.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive 10 sessions of iTBS (or the sham treatment) over two weeks, usually one session each workday. Before starting the treatment, immediately after the two weeks of treatment, and then again four weeks later, you will have several appointments for detailed checks.

These checks include looking at your negative symptoms and thinking skills, assessing your mood, and examining your eye movements. You'll also have a special type of brain scan called an fMRI, and provide blood and saliva samples. Throughout the study, the team will monitor you for any side effects or unusual feelings from the stimulation. The total duration of active participation, including follow-up, will be around six weeks.

Potential risks and benefits

Participating in this study might offer a potential benefit if the iTBS treatment helps improve your negative symptoms or thinking abilities. However, there's no guarantee it will help you personally. Like any medical procedure, there could be risks associated with the stimulation, such as discomfort, headaches, or in very rare cases, seizures. The research team will carefully monitor you for any side effects. Remember, you can decide to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hannover Medical School
Verified postcode
Hanover, Germany· Recruiting

Common questions

What are "negative symptoms"?

Negative symptoms are experiences like having low energy, reduced motivation, finding it hard to show emotions, or not enjoying activities as much as before. They are a common part of schizophrenia.

What is iTBS?

iTBS stands for intermittent theta-burst stimulation. It's a non-invasive treatment that uses magnetic pulses to stimulate specific parts of the brain to try and change how they work.

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

No, neither you nor the study team will know whether you are receiving the active iTBS or the 'sham' (dummy) treatment. This helps make the study results more accurate.

What is an fMRI scan?

An fMRI is a type of brain scan that looks at blood flow to different parts of your brain. It helps researchers see which brain areas are active during different tasks.

How long will the study appointments take?

Each stimulation session will be relatively quick, but the examination appointments (before, immediately after, and 4 weeks later) will be more involved and take longer as they include various assessments and scans.

How to find out more

Rasmus Schülke, MD (Dr. med.)

schuelke.rasmus@mh-hannover.de +49 511 532 2039 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.