RecruitingNAINTERVENTIONAL

Magnetic Brain Stimulation and Computer-based Motor Training for Rehabilitation After Stroke

This research trial is for people who have had a stroke and now find it hard to move their hands. We're testing a new approach that uses two technologies: magnetic brain stimulation and a special brain-computer interface. Magnetic brain stimulation involves using magnetic fields on the head to get the brain ready to move better. The brain-computer interface measures brain activity to create personalised computer exercises. These exercises aim to improve the communication between the brain and muscles. We hope this combined approach can help stroke survivors regain some hand function. The trial also helps us plan larger studies in the future.

At a glance

Status

Recruiting

Phase

Sponsor

Max Planck Institute for Human Cognitive and Brain Sciences

Enrolment target

Start

08 Nov 2023

Estimated completion

19 Sep 2027

Chronic Stroke

What is this study about?

This study is looking for volunteers who have had a stroke and are finding it difficult to move their hands easily. We want to see if a new way of helping people can make a difference. This approach brings together two special methods. The first is called Transcranial Magnetic Stimulation (TMS), which uses gentle magnetic fields placed on your head to stimulate certain parts of your brain. The aim is to get your brain in a better state to control movement. Think of it like giving your brain a little boost.

The second part is a Brain-Computer Interface (BCI). This isn't surgery; it involves measuring your brain activity while you do computer-based exercises. These exercises are tailored just for you based on your brain's signals. The idea is to improve how your brain talks to your muscles, hopefully making it easier for you to move your hands. By combining these two techniques, we hope to find a new and effective way to help people recover movement after a stroke.

We're also looking closely at how well this treatment works and whether people find it easy to stick with the programme. This information is very important because it will help us plan even bigger studies in the future. Our goal is to gather good evidence so that more people can benefit from these types of treatments if they prove to be helpful.

Key takeaways

Study for stroke survivors with hand movement difficulties.
Combines magnetic brain stimulation and computer exercises.
Aims to improve brain-to-muscle communication.
Involves 25 sessions over approximately three months.
You may receive active treatment or a placebo.
Helps researchers plan future, larger studies.

Who may be eligible?

To join this study, you need to have had a specific type of stroke at least six months ago, and doctors would need to see this on your brain scans (MRI or CT scan). You should also be finding it moderately or very difficult to move one of your arms or hands because of the stroke.

You should be between 20 and 80 years old, be able to understand instructions, and have good enough sight and hearing to take part in the computer exercises. Your general health should be stable, and you must be able to have MRI scans, brain activity recordings (EEG), and the magnetic stimulation without any problems.

There are reasons why you might not be able to join. For example, if you've had seizures, have certain bone or muscle conditions, other serious nerve conditions, or metal in your body. We also can't include pregnant or breastfeeding women, or if you're taking certain medications that could affect the study results.

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.

Have you had a stroke at least 6 months ago that affected your hand/arm?
Are you between 20 and 80 years old?
Can you understand instructions and participate in computer tasks?
Do you have any metal in your body, or a history of seizures or severe migraines?
Are you pregnant or breastfeeding?
Are you able to travel to the study site for regular visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have 25 study sessions in total. The first session will involve signing consent forms and setting up the brain-computer interface for you. There will be 'before' and 'after' treatment sessions (on days 2, 13, 14, and 25) where we'll check your brain activity using EEG and MRI scans, and you'll complete some tests and questionnaires about your hand movement.

The main part of the study involves two blocks of daily visits. Each block consists of 10 daily visits over two weeks (excluding weekends). In these visits, you will receive either the active magnetic brain stimulation or a 'sham' (placebo) stimulation, followed by the computer-based training. On some specific daily visits (days 3, 12, 15, and 24), we will also take blood samples before and after your treatment and training. On other daily visits (days 4-11 and 16-23), there will be no blood samples.

After the first block of 10 daily visits and an 'after-treatment' session, there will be a four-week break where you won't need to do anything for the study. Then, the whole process of 10 daily visits will repeat, followed by a final 'after-treatment' session. The total duration of your active involvement in the study will be around three months, including the break period. You will not receive any study medication.

Potential risks and benefits

Taking part in this study may or may not directly benefit you. However, you would be helping researchers learn more about how to help people recover after a stroke, which could benefit many in the future. Potential benefits include the possibility of improving your hand movement. As with any medical procedure, there are potential risks, though we aim to keep them very low. Magnetic stimulation can sometimes cause mild headaches or discomfort, and there's a very tiny chance of seizures, which is why we carefully screen participants. Blood draws can cause slight bruising or discomfort. All study procedures have been carefully reviewed for safety. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Max Planck Institute for Human Cognitive and Brain Sciences
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What is 'magnetic brain stimulation'?

It's a gentle procedure where magnetic fields are used on your head to encourage your brain to be more ready for movement. It doesn't hurt and you stay awake.

What is a 'Brain-Computer Interface'?

It's a system that measures your brain activity and uses it to personalise computer-based exercises. This helps improve how your brain and muscles communicate.

Will I know if I'm getting the real treatment or the 'sham' (placebo) treatment?

No, this is a 'blinded' study, meaning neither you nor the researchers will know who gets the active treatment until after the study is complete. This helps us ensure fair results.

How long will I need to commit to the study?

The study involves 25 sessions over approximately three months, including a four-week break in the middle.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and it will not affect your ongoing medical care.

How to find out more

Aimee Arely Flores Sandoval, MsC

flores@cbs.mpg.de +49 341 9940 Official trial record

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