Home-based transcranial direct current stimulation for major depression

Home-Based Transcranial Direct Current Stimulation in Major Depressive Disorder: a Multi-Centre, Two-Parallel Group, Superiority Randomised Controlled Trial

This trial will test whether using a small brain-stimulation device at home (tDCS) together with usual care helps adults with moderate-to-severe major depressive disorder feel better over a 10-week treatment and up to six months of follow-up.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 438 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: King's College London (Academic / other)
• Locations: 6 sites (Cardiff and 5 other locations)
• Trial ID: NCT07228468 on ClinicalTrials.gov

What this trial studies

This is a multi-centre, pragmatic randomized controlled trial comparing 10 weeks of active home-based transcranial direct current stimulation (tDCS) plus treatment as usual (TAU) versus TAU alone. About 438 adults with DSM-5 major depressive disorder and at least moderate symptoms will be randomized and followed for six months from treatment start. The primary outcome is clinician-rated depressive symptoms (MADRS); secondary outcomes include self-report mood, anxiety, remission rates, acceptability, quality of life, and health economic measures. The trial includes process and implementation work to examine feasibility and pathways for integrating home tDCS into NHS care.

Who should consider this trial

Good fit: Adults aged 18 or over with a current DSM-5 diagnosis of major depressive disorder, at least moderate symptom severity (MADRS ≥ 18), who are either medication-free or on a stable antidepressant dose and able to provide informed consent and engage with NHS follow-up are ideal candidates.

Not a fit: People with significant suicide risk, unstable medical or psychiatric comorbidity, or other contraindications to tDCS are unlikely to benefit or be eligible for this intervention.

Why it matters

Potential benefit: If successful, home tDCS could provide an effective, non-drug, scalable treatment option that reduces depressive symptoms and improves quality of life for patients who prefer alternatives to or who do not fully respond to current treatments.

How similar studies have performed: Clinic-based tDCS studies have produced mixed but promising results and small home-based pilot studies show feasibility, but large definitive RCT evidence for home tDCS is limited.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18 years or over
2. Current episode of depression based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (APA, 2013) for major depressive disorder (MDD) as 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
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 the care of GP
7. Agreeable for GP to be regularly informed about study 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-5 criteria as assessed in MINI
3. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines)
4. Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of 8 or more in Alcohol use disorders identification test consumption (AUDIT C) (Khadjesari et al., 2017; NICE, 2023)
5. History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation
6. History of esketamine / ketamine for treatment of depression
7. History of psychosurgery for depression
8. Having cognitive impairment (e.g. dementia)
9. Current medical disorder or neurological disorder that may mimic mood disorder (e.g. hormonal disorder, unstable heart disease)
10. Have any implant in the brain or neurocranial defect
11. Have shrapnel or any ferromagnetic material in the head
12. Have any active implantable medical device (e.g. pacemaker)
13. If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study
14. Concurrent enrolment in another interventional study

Where this trial is running

Cardiff and 5 other locations

• Cardiff and Vale Health Board — Cardiff, United Kingdom (Not_yet_recruiting)
• South London and Maudsley NHS Foundation Trust — London, United Kingdom (Recruiting)
• Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust — Newcastle, United Kingdom (Not_yet_recruiting)
• Northamptonshire Healthcare NHS Foundation Trust — Northampton, United Kingdom (Not_yet_recruiting)
• Nottinghamshire Healthcare NHS Foundation Trust — Nottingham, United Kingdom (Not_yet_recruiting)
• Hampshire and Isle of Wight Healthcare NHS Foundation Trust — Southampton, United Kingdom (Not_yet_recruiting)

Study contacts

• Principal investigator: Cynthia Fu, MD, PhD — King's College London
• Study coordinator: Cynthia Fu

Conditions Major Depressive Disorder; transcranial direct current stimulation; tDCS; major depression; MDD; major depressive disorder; brain stimulation