Active not recruitingNAINTERVENTIONAL

Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE

This study is exploring a new way to help people living with Myalgic Encephalomyelitis, also known as Chronic Fatigue Syndrome (ME/CFS). It uses a technique called transcranial direct current stimulation (tDCS), which involves applying a very mild electrical current to the head. This treatment will be done at home with remote supervision. We aim to find out if this treatment is practical and easy for patients to use, if people can do it regularly, and if it helps improve their symptoms. We'll also check if it's safe and well-tolerated. This is a small study involving 20 individuals aged 18 to 70.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Regensburg

Enrolment target

Start

16 Mar 2023

Estimated completion

31 Mar 2026

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

What is this study about?

Living with Myalgic Encephalomyelitis (ME) or Chronic Fatigue Syndrome (CFS) can be really tough, often leaving people feeling extremely tired and unwell. Scientists are always looking for new ways to help manage these symptoms. This particular study is investigating a new treatment that you might be able to use comfortably at home. It's called transcranial direct current stimulation, or tDCS for short.

tDCS involves placing small pads on your head that deliver a very gentle electrical current. It's not painful and is thought to help stimulate certain areas of the brain. The idea is to see if this stimulation can help reduce the severe fatigue and other symptoms associated with ME/CFS. Because this treatment is done at home, it could be more convenient for people who find it difficult to travel.

The main goals of this study are to understand if this home-based treatment is easy for people to use, if they can complete the treatment sessions as planned, and if the remote supervision works well. We also want to see if people feel better after using it and if it's a safe and comfortable treatment option for those with ME/CFS. This information will help researchers decide if this treatment should be studied on a larger scale in the future.

Key takeaways

This study explores a home-based electrical stimulation treatment for ME/CFS.
It aims to check if the treatment is practical, safe, and potentially helpful for fatigue.
Participants can be aged 18 to 70 and must have an ME/CFS diagnosis.
Treatment is done at home with professional guidance.
It's a small, early-stage study, not a guaranteed treatment.
Your contribution helps advance research for ME/CFS.

Who may be eligible?

This study is looking for people who have been officially diagnosed with Myalgic Encephalomyelitis (ME/CFS) based on specific medical guidelines called the Canadian Consensus Criteria. You also need to live near Regensburg in Germany and your main language must be German. If you are taking any regular medication, it should be stable, meaning the dosage hasn't changed recently and you're not planning to change it during the study.

There are some reasons why you might not be able to join. For example, if you have certain health conditions that would make the electrical stimulation treatment unsafe for you. These can include particular brain or nerve conditions, which a study doctor would check. You also can't be pregnant or breastfeeding, or already taking part in another medical study.

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.

Do you have an official diagnosis of ME/CFS?
Are you between 18 and 70 years old?
Do you live near Regensburg, Germany, and speak German?
Are you not pregnant or breastfeeding?
Are you not currently part of another medical study?
Do you not have any health conditions that would make electrical stimulation unsafe for you (a doctor will check this)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a special device to use at home for the tDCS treatment. You'll be shown how to use it, and you'll complete your treatment sessions remotely, meaning you won't need to visit a clinic for every session. You'll have check-ups to assess how you're feeling and to see if the treatment is helping your fatigue and other symptoms. The research team will guide you on how often and for how long you'll need to use the device. The exact duration of your participation will be explained by the study team.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment that could potentially help reduce your ME/CFS symptoms, though there's no guarantee it will work for everyone. You would also be contributing valuable information that could help others with ME/CFS in the future. As with any medical study, there can be some potential risks, such as mild skin irritation where the pads are placed, or other temporary side effects from the electrical stimulation. The study doctors will carefully explain all known risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Department of Psychiatry and Psychotherapy, University of Regensburg
Verified postcode
Regensburg, Germany

Common questions

What is tDCS?

tDCS stands for transcranial direct current stimulation. It's a non-invasive way to apply a very gentle electrical current to specific areas of the head, which some believe can help change brain activity.

Will the electrical current hurt?

No, the electrical current used in tDCS is very mild and is not painful. Some people report a slight tingling sensation on their skin.

How long will I be in the study?

The study involves a set period of treatment and follow-up. The research team will tell you the exact duration when you inquire about participation.

Do I need to go to a clinic for treatment?

No, this study is designed for home-based treatment with remote supervision, meaning you'll do the treatment at home after initial training.

Can I still take my regular medication if I join?

Yes, as long as your medication is stable and not expected to change during the study, you can continue taking it.