RecruitingNAINTERVENTIONAL

At-Home tDCS as Maintenance Therapy

This study is for adults in the UK who have struggled with severe depression and have recently improved after hospital treatments like esketamine, rTMS, or ECT. Researchers want to see if using a small, gentle electrical device on your head at home, called tDCS, can help you stay feeling better. The main aims are to find out if it's easy and safe for people to use the device at home, and if it shows early signs of keeping depression symptoms from coming back. If you join, you'll use a portable tDCS device for about 30 minutes a day, five times a week for four weeks, with support and check-ups from the study team.

At a glance

Status

Recruiting

Phase

Sponsor

Technical University of Munich

Enrolment target

Start

01 Oct 2024

Estimated completion

29 Nov 2026

MDD Severe Depression Major Depressive Episode

What is this study about?

This study is looking into a new way to help people who have experienced severe depression to stay well after their initial treatment. Many people who get better after hospital-based treatments like esketamine, rTMS, or ECT worry about their depression symptoms returning. This research explores whether a technique called transcranial direct current stimulation (tDCS) can act as a "maintenance therapy" to help prevent this.

tDCS involves using a small device that sends a very gentle electrical current through two sponges placed on your head. This current is so mild that you might only feel a slight tingle, and it's designed to gently influence brain activity in areas that are linked to your mood. The idea is to see if regular, short sessions of tDCS done at home could help keep your mood stable and prevent depression symptoms from worsening again.

The main goals of this study are twofold. Firstly, the researchers want to know if using this device at home is practical and comfortable for people (we call this "feasible" and "well tolerated"). Secondly, they are looking for early signs that tDCS can indeed help maintain the positive effects achieved during earlier hospital treatment. This is a pilot study, meaning it’s an early step to see if this approach is promising enough for larger studies in the future.

Key takeaways

This study explores a home-based device to help prevent depression symptoms from returning.
It uses a gentle electrical stimulation (tDCS) on the head.
Participation involves 20 home sessions over 4 weeks, with app support.
It's for adults who have improved after hospital depression treatments.
The main goals are to check if it's safe, easy to use, and shows early signs of effectiveness.
There's a focus on privacy and safety with the device and data.

Who may be eligible?

This study is looking for adult volunteers, aged 18 or older, who have been diagnosed with a depressive disorder, such as recurrent severe depression. A key requirement is that you have already received acute treatment (like esketamine, rTMS, or ECT) for your depression at a hospital and have shown significant improvement or stabilisation of your symptoms.

There are certain reasons why someone might not be able to join. For example, if you are currently in an acute depressive crisis, have a high risk of suicide, or have certain medical conditions or implants (like some types of ear implants or severe skin conditions on your head) that would make tDCS unsafe for you. People who haven't responded well to previous treatments or have other serious health conditions that could interfere with the study's safety or results will also not be included.

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 18 years old or older?
Have you been diagnosed with a past depressive disorder?
Have you recently improved after hospital treatment for depression (e.g., esketamine, rTMS, or ECT)?
Are you able to provide your consent to take part?
Do you have any implants near your head or severe skin conditions on your scalp that might make tDCS unsafe?
Are you currently thinking about harming yourself?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves several steps over about six weeks. First, you'll receive clear instructions from trained staff on how to use the tDCS device and prepare for a session. You'll be given a portable tDCS device, a cap, and small sponge electrodes to use at home.

You will then complete 20 sessions of tDCS over four weeks, which means doing it five times a week. Each session lasts 30 minutes, and the device will gently increase and decrease the electrical current for your comfort. You'll use a smartphone app for guidance, reminders, and to automatically log your sessions. You will also fill out short questionnaires weekly to report on your mood and have brief phone check-ins with the study team every two weeks.

After the four weeks of treatment, there will be a two-week follow-up period, ending with a final assessment. Your ongoing medications or psychotherapy can continue as normal during the study and will not be changed by the research team. The study team is based at a clinic in Munich, Germany, so phone check-ins will likely be from there.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping you to maintain the improvements in your depression symptoms achieved from previous treatments, potentially reducing the chance of them returning. However, it's important to remember this is a pilot study, so it's not guaranteed that tDCS will help. Potential risks are generally mild; you might feel a slight tingling sensation on your scalp during sessions or experience some skin redness where the electrodes are placed. The device is designed with safety features, like monitoring electrode contact and pausing if it's poor. Your personal information and session data will be kept private and secure. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (2)

Technical University of Munich, TUM School of Medicine and Health, Department of Psychiatry and Psychotherapy, Munich,
Verified postcode
München, Germany· Enrolling by invitation
Department of Psychiatry and Psychotherapy, Technical University of Munich, University Hospital
Verified postcode
München, Germany· Recruiting

Common questions

What exactly is tDCS?

tDCS stands for transcranial direct current stimulation. It's a method that uses a very gentle, constant electrical current delivered through small sponges on your head to softly change brain activity in areas related to mood.

How often would I need to use the tDCS device?

You would use the device for 30 minutes, five times a week, for a total of four weeks. This is usually 20 sessions in total.

Will I have to go to the clinic often?

Most of the treatment takes place at home. You'll have phone check-ins every two weeks and fill out questionnaires weekly, but regular clinic visits for the tDCS sessions are not required after initial training.

What if I feel uncomfortable during the tDCS sessions?

The device gently adjusts the current to help with comfort, and any sensations like tingling are usually mild. If contact is poor, the device automatically pauses. You can also stop a session if you are uncomfortable.

Can I continue my regular medication or therapy during the study?

Yes, you can continue your ongoing medications or psychotherapy as usual during the study. They will not be changed as part of this research.

How to find out more

Ulrike Vogelmann, Dr. med.

ulrike.vogelmann@mri.tum.de +4917661535471 Official trial record

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