Home-use brain stimulation for bipolar depression

Home-based Transcranial Direct Current Stimulation in Bipolar Depression: a Randomised, Double-blind, Placebo-controlled Trial

This trial will test whether a home-use tDCS headset can reduce depressive symptoms in adults with bipolar disorder compared with a placebo (sham) device.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 212 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: King's College London (other)
• Locations: 1 site (London)
• Trial ID: NCT07556692 on ClinicalTrials.gov

What this trial studies

This is a controlled study comparing active transcranial direct current stimulation (tDCS) delivered with the Flow FL-100 headset to a placebo (sham) version of the device used at home. Adult participants with DSM-5 bipolar disorder who are currently in a depressive episode and meet a minimum severity threshold (MADRS ≥18) are eligible after structured clinical assessment. The study will measure changes in depressive symptoms, monitor safety, and record how acceptable and usable the home device is for participants. Researchers will require informed consent and regular communication with participants' GPs as part of the protocol.

Who should consider this trial

Good fit: Adults aged 18 or older with DSM-5 bipolar disorder currently in a depressive episode with at least moderate symptom severity (MADRS ≥18) and who meet the study's safety and stability criteria are ideal candidates.

Not a fit: People with significant suicide risk or other safety exclusions, or those unable or unwilling to use a home-based headset, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide an accessible, low-risk at-home treatment option to help reduce depressive symptoms in people with bipolar disorder.

How similar studies have performed: tDCS has shown promise in previous studies for major depressive disorder, but home-based tDCS and its use specifically for bipolar depression remain less well studied.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18 years or over.
2. Diagnosis bipolar disorder in a current depressive episode based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al.,1998).
3. Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS (Montgomery and Åsberg, 1979).
4. Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.
5. Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.
6. Being under care of GP.
7. Agreeable for GP to be regularly informed by research team about participation.
8. Able to provide written, informed consent.

Exclusion Criteria:

1. Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011).
2. Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM criteria as assessed in MINI (Sheehan et al., 1998).
3. Having a Young Mania Rating Scale (Young et al., 1978) score of 20 or more.
4. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines).
5. Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of \> 8 in Alcohol use disorders identification test consumption (AUDITC) (Khadlesari et al., 2017; NICE, 2023).
6. History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), other brain stimulation, or psychosurgery for depression.
7. History of esketamine / ketamine for treatment of depression.
8. Medical disorder that may mimic mood disorder (e.g. hormonal disorder).
9. History of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.
10. Have cognitive impairment (e.g. dementia).
11. History of a neurological disorder (e.g., cerebrovascular events, stroke, structural lesion, epilepsy, seizures, Parkinson's disease).
12. History of migraines or intractable headaches.
13. Implant in brain, neurocranial defect or active implantable medical device.
14. Shrapnel or any ferromagnetic material in head.
15. If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study
16. Concurrent enrolment in another interventional study.

Where this trial is running

London

• South London and Maudsley NHS Foundation Trust — London, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Professor Cynthia Fu

Conditions: Bipolar Disorder