RecruitingNAINTERVENTIONAL

A Study of Home-use Brain Stimulation to Treat Bipolar Depression

This study is investigating a new way to help people with bipolar disorder who are experiencing depression. Many people still struggle with depressive symptoms even after trying standard treatments. The study uses a special headset called the Flow FL-100 that sends a very small electrical current to the brain, a method known as tDCS. This type of treatment has shown promise for depression. Researchers want to see if using this device at home is effective and safe compared to a dummy treatment. They also want to understand how acceptable the device is to users and how well people can use it on their own to improve their mood.

At a glance

Status

Recruiting

Phase

Sponsor

King's College London

Enrolment target

212

Start

24 Apr 2026

Estimated completion

30 Nov 2027

Bipolar Disorder (BD)

What is this study about?

Bipolar disorder can cause long periods of feeling very down, known as bipolar depression. For many, even with current treatments, these depressive feelings can be tough to shake off. This study is exploring a new approach using a device called the Flow FL-100 tDCS headset.

tDCS stands for 'transcranial direct current stimulation'. It's a gentle way of stimulating the brain using a very small electric current that passes through the scalp. This method has shown some potential in helping people with depression. This research aims to find out if using this tDCS device at home can genuinely help reduce symptoms of bipolar depression and if it's safe to use compared to a 'sham' treatment (which looks and feels real but doesn't deliver the actual current).

Beyond just seeing if it works, the study will also look at how people feel about using the device at home and how easy it is for them to follow the instructions. The information gathered from this study could be very important in developing new and more effective ways to help people living with bipolar depression in the future.

Key takeaways

A new study is exploring a home-use device for bipolar depression.
The device uses a gentle electrical current called tDCS to stimulate the brain.
The study aims to check if the device is effective, safe, and easy to use at home.
Participation involves using a device and completing mood assessments from home.
Potential benefits include improved mood; side effects are usually mild and temporary.
It could help improve future treatments for bipolar depression.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with bipolar disorder and are currently experiencing a depressive episode. You'll need to have a certain level of depressive symptoms to qualify, which will be checked by the research team.

There are also some criteria that mean you wouldn't be able to join. For example, if you have a high risk of harming yourself, or if you have another major mental health condition beyond bipolar disorder. Certain medications, heavy alcohol use, or specific past brain treatments (like ECT or TMS) would also exclude you. The research team will carefully check all these details to make sure the study is right and safe for you.

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?
Do you have a diagnosis of bipolar disorder?
Are you currently feeling depressed?
Are you happy for your GP to be informed about your participation?
Have you not had certain brain stimulation treatments in the past (like ECT)?
Do you not have a high risk of harming yourself?

Answer every question to see your result.

What does participation involve?

If you join this study, the research team will first check to make sure it's suitable for you. This will involve some assessments. You'll then be randomly assigned to one of two groups: one group will receive the actual tDCS device, and the other will receive a 'sham' device (which looks the same but doesn't deliver the active treatment). Neither you nor the researchers who check your progress will know which treatment you are receiving.

You'll use the study device at home for a set period. Throughout the study, you'll have check-ups at certain times. These will include discussions with a medical professional and filling out questionnaires about your mood and how you're feeling. The study will mainly be done remotely from your home, though it's run by King's College London with other NHS sites across the UK. The study is expected to run from April 2026 to October 2027.

Potential risks and benefits

You might find that your depressive symptoms improve by taking part in this study. Also, the information we learn from this research could help improve future treatments for bipolar depression for many others. Generally, tDCS is well-tolerated. Some people might experience mild and temporary side effects, such as tingling, itching, a headache, or skin irritation where the device is placed. All participants will be closely watched for any side effects, and support will be available if you need it. Remember, you can decide to stop participating in the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

South London and Maudsley NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is bipolar depression?

Bipolar depression is a phase of bipolar disorder where someone experiences strong feelings of sadness, low energy, and a lack of interest in activities.

What is tDCS?

tDCS (transcranial direct current stimulation) is a gentle treatment that uses a very small electrical current applied to the head to stimulate the brain.

Will I know if I'm getting the real treatment?

No, you won't know if you're getting the active device or a dummy one. This is so the results are fair and unbiased.

How long will the study last?

The study is running from April 2026 to October 2027. Your individual involvement would be for a specific period within that timescale, which the researchers will explain.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Professor Cynthia Fu

cynthia.fu@kcl.ac.uk 0207848832 Official trial record

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