RecruitingNAINTERVENTIONAL

Intensive-neurofeedback Protocol for Children With ADHD: A Proof-of-concept Study Comparing iAPF-personalized and Standard Theta-beta-ratio Training

This research study is looking into a type of brain training called neurofeedback for children aged 6-13 who have ADHD. The aim is to see if this special training, done in holiday camps, can help reduce symptoms like difficulty paying attention, being overly active, and acting on impulse, which are common with ADHD. Researchers want to compare two different ways of doing neurofeedback: a standard method and a newer, more personalised approach. They believe the personalised method might work better. They'll be checking children's progress right after the training and again six months later to see if the improvements last. It's a first step to understand if this personalised training is a good way forward.

At a glance

Status

Recruiting

Phase

Sponsor

Bielefeld University

Enrolment target

Start

09 Jul 2024

Estimated completion

31 Dec 2026

ADHD Inattention Hyperactivity Impulsivity Executive Dysfunction

What is this study about?

This study is exploring a special type of brain training called neurofeedback for children with ADHD. Think of neurofeedback as a way to help your brain learn to focus better. It’s a bit like playing a video game using only your brain signals recorded through sensors placed on your head. The idea is that specific brain wave patterns are linked to ADHD symptoms, and neurofeedback can help children learn to change these patterns.

Researchers are comparing two different ways of providing this training. One is a "standard" method, which is the same for everyone. The other is a "personalised" method, where the training is specifically adjusted to each child's own brain wave patterns. The study wants to find out if this more personalised training works better at reducing ADHD symptoms like being easily distracted, very active, or acting without thinking. They'll also check if children can concentrate better and make decisions more effectively.

The training will take place during school holidays in a camp-like setting, with two sessions each day over eight days. The study will look at how children are doing immediately after the training and then again six months later to see if any improvements are lasting. This is a "proof-of-concept" study, which means it's an important first step to see if this personalised approach is promising enough to be studied in larger groups of children in the future.

Key takeaways

New study compares two brain training methods for children with ADHD.
One method is standard; the other is personalised to the child's brain.
Training takes place during school holiday camps, two sessions a day for eight days.
Aims to reduce ADHD symptoms like inattention, hyperactivity, and impulsivity.
Evaluates effects immediately after training and again after six months.
This is a small, initial study to see if the personalised method is worth further research.

Who may be eligible?

This study is looking for children aged 6 to 13 years old who have a confirmed diagnosis of ADHD. They also need to be able to speak German and have normal or corrected vision (like wearing glasses or contact lenses).

Children cannot take part if they have certain other brain conditions, such as epilepsy. If a child doesn't have an official ADHD diagnosis, they also won't be able to join. Parents or guardians must be able to give their consent and fill out questionnaires about their child.

If your child has had neurofeedback training in the past year or is currently having it, they won't be able to join this study. However, children who are taking ADHD medication or having other talking therapies can still take part, as long as any medication they're on stays at the same dose throughout the training period.

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.

Is your child aged between 6 and 13 years old?
Does your child have a confirmed diagnosis of ADHD?
Can your child understand and speak German?
Does your child have normal or corrected eyesight?
Has your child NOT had neurofeedback training in the last year, and is not currently having it?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will be randomly assigned to one of two groups: either the standard neurofeedback training or the personalised neurofeedback training. Both groups will attend a camp during school holidays, where they will have two training sessions each day over eight days, making a total of 16 sessions.

Before, immediately after, and six months after the training, your child will have assessments. These include filling out questionnaires (by parents, teachers, and the child themselves if old enough) about ADHD symptoms, and your child will do some tasks to check their attention and decision-making skills. Brain wave recordings (EEG) will also be taken during these assessment points. The total duration of active participation (training sessions and initial follow-up) is over eight days, with a final check-up after six months.

Potential risks and benefits

Taking part in this study may offer your child the potential benefit of improved ADHD symptoms through a new, personalised brain training method. However, as it's a research study, there's no guarantee of direct benefit for every child, and some children might not experience significant changes. There are generally no serious physical risks associated with neurofeedback, but some children might find the sessions tiring or temporarily frustrating. You always have the right to withdraw your child from the study at any time, for any reason, without it affecting their current or future medical care.

Locations (2)

Bielefeld University
Verified postcode
Bielefeld, Germany· Recruiting
Philipps-University Marburg
Verified postcode
Marburg, Germany· Recruiting

Common questions

What is neurofeedback?

It's a type of brain training that helps people learn to control their brain waves, often used to improve focus and reduce ADHD symptoms.

What does 'personalised' training mean?

It means the training is adjusted specifically for your child's unique brain patterns, rather than being a general approach for everyone.

Will my child stop their ADHD medication for this study?

No, children can continue taking their ADHD medication, but the dose should remain stable throughout the training period.

How long does the training last?

The training consists of two sessions a day for eight days during school holidays, making 16 sessions in total.

What happens after the training finishes?

Researchers will check your child's progress right after the training and again six months later to see if any improvements last.

How to find out more

Luisa Himmelmeier, M.Sc. Psychology

lhimmelmeier@uni-bielefeld.de +49 (0) 521 106 67534 Official trial record

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