BDEP
Research type
Research Study
Full title
Home-based transcranial direct current stimulation in bipolar depression: a randomised, double-blind, placebo-controlled trial
IRAS ID
348113
Contact name
Cynthia H.Y. Fu
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Bipolar disorder is severe and disabling, but is often an overlooked mental health condition. Individuals with bipolar disorder spend more time being depressed than manic or hypomanic. However, there are fewer treatments for bipolar depression than for manic or hypomanic episodes. Treatments usually involve medications and psychotherapy, but medications can have side effects, such as weight gain, and treatments are not always helpful for everyone. We work with patient and public involvement (PPI) members who say how important it is to have more treatment options.
Transcranial direct current stimulation (tDCS) is a new potential treatment for bipolar depression. The tDCS device is a headset placed over the forehead. Inside the headset are a couple of rubber electrodes. The electrodes produce a small electrical current that makes it easier for brain cells to discharge or to 'fire' off a signal. In this way, the current can boost or calm brain activity. tDCS does not make brain cells discharge, which happens in transcranial magnetic stimulation (TMS), and it does not lead to a seizure, which happens in electroconvulsive therapy (ECT).
tDCS is easy to use. It's portable and safe. We have developed a program so that tDCS can be used at home, and we provide real-time supervision via video conference. We have recently done a study of home-based tDCS treatment in bipolar depression. We wanted to see if it would be safe to provide tDCS at home, and everyone received active tDCS. We found that everyone liked having the sessions at home, and depressive symptoms improved for most participants. It was safe. No one developed manic or hypomanic symptoms. The most common side effects were tingling during the session and some skin redness where the electrodes were, which got better after the session.
In this study, we would like to see if active tDCS given at home can help to improve depressive symptoms in bipolar depression better than inactive tDCS. We will invite individuals with bipolar depression who are seeing their GP or community mental health team. Everyone will receive tDCS treatment at home in addition to their usual care. Half the participants will receive the active device and half will receive the inactive device. The inactive tDCS is exactly the same device as active tDCS, but it does not have a current. We will give the devices in a random manner, like a toss of a coin, and neither participants nor research team members will know which treatment they are receiving. Each tDCS session lasts 30 minutes. There are five sessions per week for three weeks and then three sessions per week for seven weeks. Participants who had received the inactive device will also receive the active device after 6 months.
We will look at whether there is a greater improvement in depressive symptoms with active tDCS compared with inactive tDCS. We will meet with participants to discuss how they found the sessions and if it made a difference in their quality of life. We will look at whether the treatment is safe. Our PPI team members have helped to design this study, will continue to advise and help us during the study, and will help to share the findings. We will share findings in research journals and talks, and more widely in social media, websites, infographics and newsletters. To have a new effective treatment in the NHS that can be used at home could be life-changing for individuals with bipolar depression.
The study will be conducted at 5 NHS Foundation Trusts in England and Wales, and due to the remote design of the trial we are able to enrol people from throughout England and Wales, not only those who live near the research sites.
The study is being funded by the National Institute of Health and Care Research Efficacy and Mechanism Evaluation funding programme. Overall, we expect the study to last for 2 years and 1 month.
REC name
London - Dulwich Research Ethics Committee
REC reference
26/LO/0035
Date of REC Opinion
25 Mar 2026
REC opinion
Further Information Favourable Opinion