RecruitingPHASE1, PHASE2INTERVENTIONAL

Brain Signal Training to Enhance Affect Down-regulation

This study, called 'Brain Signal Training to Enhance Affect Down-regulation' (BrainSTEADy), is for people aged 18-65 with Borderline Personality Disorder (BPD). BPD can cause intense and unstable negative emotions. Researchers believe that a part of the brain called the amygdala might be overactive in BPD, leading to these strong emotional reactions. This study uses a technique called neurofeedback, which is like brain training. Participants will learn to control their brain activity in the amygdala to help calm emotional overreactions. The goal is to see if this brain training specifically helps reduce emotional instability in daily life, beyond any general benefits. It's a phase 1 and 2 study, meaning it's an early step in testing this new approach.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Central Institute of Mental Health, Mannheim

Enrolment target

164

Start

23 Apr 2025

Estimated completion

01 Jun 2028

Borderline Personality Disorder

What is this study about?

People with Borderline Personality Disorder (BPD) often experience very intense and rapidly changing negative emotions. This can make daily life and relationships very challenging. Scientists believe that a part of the brain called the amygdala, which plays a big role in our emotions, might be too active in people with BPD. This overactivity could be a reason for their strong emotional reactions and difficulty controlling their feelings.

This study is looking at a new type of training called 'neurofeedback'. Imagine your brain activity is like a temperature on a thermometer. With neurofeedback, you can see 'live' how active your amygdala is. When you see it getting too active, the training teaches you how to consciously try and calm it down, like trying to lower the temperature. The idea is that with practice, you can learn to better control these brain responses and, in turn, manage your emotions more effectively.

The BrainSTEADy study wants to find out if this amygdala neurofeedback training really helps people with BPD reduce their emotional ups and downs. Participants will have several training sessions where they learn to control their brain activity while looking at pictures that might trigger emotions. Researchers will then check if this training makes a real difference in how they experience and manage their emotions in everyday life. This is an important step in exploring new ways to help people living with BPD.

Key takeaways

This study explores a new 'brain training' for BPD.
It aims to help control intense emotions by targeting a brain area called the amygdala.
Participation involves several 'neurofeedback' sessions in an MRI scanner.
It's for adults aged 18-65 with BPD who haven't fully responded to other therapies.
The goal is to see if this training specifically reduces emotional instability.

Who may be eligible?

To join this study, you need to be an adult between 18 and 65 years old and have a diagnosis of Borderline Personality Disorder. It's important that you've already tried at least two other therapies for BPD that haven't fully helped you. You must also be able to understand and speak German well enough to follow all study instructions and fill out questionnaires.

There are also some reasons why you wouldn't be able to join. For example, if you've recently taken certain calming medicines (benzodiazepines) or currently have problems with alcohol or drug dependence. People with certain mental health conditions like a history of psychosis or schizophrenia, or significant brain conditions like previous strokes, also can't take part. We also need to make sure you're comfortable inside an MRI scanner, as the training involves being in one.

It's important that you're not planning to change your current BPD treatments (medication or talking therapy) during the study period, and you shouldn't have had any other neurofeedback training recently. If you're a woman who could become pregnant, you'll need to use reliable contraception.

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 65 years old?
Have you been diagnosed with Borderline Personality Disorder?
Have you tried at least two other therapies for BPD without full success?
Are you able to speak and understand German well?
Are you comfortable inside an MRI scanner and don't have metal implants?
Are you not using certain calming medicines or struggling with alcohol/drug dependence?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be one of 164 patients taking part, split between four different locations in Germany: Tuebingen, Freiburg, Giessen, and Mannheim. The study involves four training sessions. Before and after these sessions, researchers will check how your emotional stability is in your daily life.

During the neurofeedback sessions, you'll be in an MRI scanner. While you look at pictures that might cause negative emotions, you'll see a 'thermometer' that shows your brain's activity in the amygdala. The task is to learn how to keep this 'temperature' (brain activity) down. This is designed to help you master emotional overreactions. The study also involves making sure you meet specific health and language requirements before you start. The total duration of your involvement will include these training sessions and assessments before and after.

Potential risks and benefits

Taking part in this study may offer a potential benefit by helping you learn new ways to manage intense emotions through brain training, which could improve your daily life. However, there's no guarantee that it will help everyone. As with any medical study, there are potential risks, such as discomfort during the MRI scans or the training not being effective for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

University clinic Freiburg
Verified postcode
Freiburg im Breisgau, Germany· Recruiting
University clinic Giessen
Verified postcode
Giessen, Germany· Recruiting
University Clinic Halle (Saale)
Verified postcode
Halle, Germany· Not yet recruiting
University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany· Recruiting
Central Institute of Mental Health
Verified postcode
Mannheim, Germany· Recruiting
University Clinic Tuebingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is Borderline Personality Disorder (BPD)?

BPD is a mental health condition that can cause intense emotional ups and downs, relationship difficulties, and a fluctuating sense of self.

What is neurofeedback?

Neurofeedback is a type of brain training where you see your own brain activity in real-time and learn to control it to improve specific mental processes.

What is the amygdala?

The amygdala is a small part of your brain that plays a key role in processing emotions, especially fear and anxiety.

Will I have to take any new medicines?

The study does not involve new medications, but you might need to avoid certain existing medications for a short time before and during the study to ensure accurate results.

How long will the study last?

The study involves four training sessions and assessments before and after. The exact total duration will be discussed with you upon enrollment.

How to find out more

Christian Paret-Voigt, Dr.

christian.paret@zi-mannheim.de +4962117034462 Official trial record

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