Transcranial Direct Current Stimulation Therapy for Bipolar Depression

Status Recruiting

Clinical Trial Summary

Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent. The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.

Clinical Trial Description

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar disorder. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a headband worn over the forehead with two electrodes, which are small metal discs, where the current comes from. tDCS does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ECT) and it does not induce brain cells to discharge like transcranial magnetic stimulation (TMS). Clinical studies have shown that tDCS treatment could help to improve the symptoms of depression. The main side effects have been redness, skin irritation or sensations (itching, tingling or burning) under the electrodes. Less commonly reported side effects include headache or tiredness. tDCS is a portable and safe treatment. The studies to date have mostly looked at tDCS treatment which has been provided in a research setting. This is a problem because the treatment requires daily sessions for several weeks which could limit whether individuals would be able to go every day. As tDCS is a portable and safe treatment, it could be provided in the community. The present study is a proof-of-concept trial to assess the efficacy, acceptability and safety of tDCS treatment for bipolar depression within a community-based setting. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05436613
Study type	Interventional
Source	University of East London
Contact	Cynthia Fu, MD, PhD
Phone	0208 223 4119
Email	C.Fu@uel.ac.uk
Status	Recruiting
Phase	N/A
Start date	May 1, 2022
Completion date	June 30, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.