RecruitingOBSERVATIONAL

German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation

This study, called the German Registry of Alzheimer's Disease Treated With Transcranial Pulse Stimulation, is exploring a new treatment for Alzheimer's disease called Transcranial Pulse Stimulation (TPS). The main goal is to check how safe TPS is for people with Alzheimer's. Researchers also want to understand how effective it might be and how easy it is to use in clinics. They will collect information from many different clinics, looking at whether the treatment improves symptoms, and keeping a close eye on any side effects. This information will help them make the treatment even better and safer in the future.

At a glance

Status

Recruiting

Sponsor

Heinrich-Heine University, Duesseldorf

Enrolment target

100

Start

06 Aug 2025

Estimated completion

01 Oct 2026

Alzheimer Disease

What is this study about?

This study is investigating a treatment called Transcranial Pulse Stimulation, or TPS, for people with Alzheimer's disease. Alzheimer's is a condition that affects memory and thinking. TPS uses a special kind of energy pulse to target certain areas of the brain. The main purpose of this study is to find out how safe TPS is when used by people with Alzheimer's.

Beyond safety, the study also aims to understand how well TPS works to improve symptoms of Alzheimer's. It will also look at how practical and easy the treatment is to use in different medical settings. This is a "Post-Market Clinical Follow-up" study, which means the treatment is already available, and this study helps gather more real-world information about its use.

Throughout the study, doctors will carefully record any side effects that people experience, whether they are common or rare. They will also monitor changes in thinking, memory, mood, and how people generally feel. By collecting all this information from many different clinics, researchers hope to improve how TPS is given and better understand its effects on people with Alzheimer's disease.

Key takeaways

This study investigates the safety and effectiveness of a treatment called Transcranial Pulse Stimulation (TPS) for Alzheimer's disease.
It aims to understand how well TPS works to improve symptoms and its ease of use in clinical settings.
Researchers will closely monitor for any side effects and changes in thinking, memory, and mood.
Participation involves receiving TPS treatment at a specialist clinic and undergoing regular assessments.
The study is for people aged 18-85 with a diagnosed type of Alzheimer's disease.
You can withdraw from the study at any time.

Who may be eligible?

To be part of this study, you would need to be between 18 and 85 years old. You should have a diagnosis of Alzheimer's disease that has been gradually affecting your memory for at least six months and causing some difficulties with daily activities.

Doctors might also look at certain brain scans (like an MRI) or other tests to confirm the Alzheimer's diagnosis, though these specific tests are not always required. You would need to receive the TPS treatment at a specialist neurological or psychiatric clinic, under the care of a doctor.

However, there are some reasons why you might not be able to join. These include certain other brain conditions not related to Alzheimer's, like advanced blood vessel issues in the brain, previous strokes, tumours, pregnancy, or if you have metal implants in your brain. You also can't participate if you have bleeding problems, take certain blood-thinning medicines, or have epilepsy. Finally, if there's any medical reason that would make it hard for you to follow the study's instructions, you might not be eligible.

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 85 years old?
Have you been diagnosed with Alzheimer's disease that has affected your memory for at least six months?
Do you receive your medical care at a specialist neurological or psychiatric clinic?
Do you have any metal implants or other specific brain conditions (not related to Alzheimer's)?
Do you have any bleeding disorders or epilepsy?
Are you pregnant or could you be pregnant?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will receive the Transcranial Pulse Stimulation (TPS) treatment. The study involves regular visits to a specialist clinic where you will undergo the TPS sessions. During these visits, doctors will assess your memory, thinking, and mood using various tests. They will also ask you about any side effects you might be experiencing. The specific number of visits and the total duration of your participation are not detailed but will involve ongoing assessments as you receive the TPS treatment. You will not be given any new medications specifically for this study, as it focuses on the TPS treatment itself.

Potential risks and benefits

Participating in this study might offer a potential benefit if the Transcranial Pulse Stimulation (TPS) treatment helps improve your Alzheimer's symptoms. However, as with any medical procedure, there are potential risks, and you might experience side effects. These will be carefully monitored throughout the study. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without explaining your reasons, and your medical care will not be affected.

Locations (6)

Ernst von Bergmann Klinikum - Klinik für Neurologie und Klinische Neuropsychologie
Verified postcode
Potsdam, Germany· Recruiting
Evangelische Krankenhausstiftung Oldenburg - Universitätsklinik für Neurologie
Verified postcode
Oldenburg, Germany· Not yet recruiting
Universitätsklinikum Bonn - Klinik für Parkinson, Schlaf- und Bewegungsstörungen
Verified postcode
Bonn, Germany· Not yet recruiting
Neurologische Praxis Prof. Wojtecki
Verified postcode
Neuss, Germany· Not yet recruiting
Hospital zum Heiligen Geist GmbH & Co KG Klinik für Neurologie und Neurorehabilitation
Verified postcode
Kempen, Germany· Withdrawn
Praxis Dr. Schwarz
Verified postcode
Ulm, Germany· Recruiting

Common questions

What is Transcranial Pulse Stimulation (TPS)?

TPS is a treatment that uses special energy pulses to target specific areas of the brain, being explored for conditions like Alzheimer's disease.

What is the main goal of this study?

The main goal is to find out how safe TPS is for people with Alzheimer's disease, and also to see how well it works and how practical it is to use.

Will I have to take new medicine?

No, this study focuses on the TPS treatment itself, not on new medications.

What happens if I want to stop taking part?

You can leave the study at any time you wish, and your decision will not affect your usual medical care.

Who is funding this research?

The study details don't mention specific funding, but it's often supported by medical device companies or research grants.

How to find out more

Lars Wojtecki, Prof. Dr.

wojtecki@uni-duesseldorf.de +492118106756 Official trial record

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