Home-Based Transcranial Direct Current Stimulation In Major Depressive Disorder (HOME)

Summary

Depression is a prevalent and debilitating disorder. The most common treatments are antidepressant medications and talking therapies. However, for many individuals, these are not their treatment of choice. Furthermore, even following a full course of treatment with an antidepressant or talking therapy, over one third of patients continue to be unwell.

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. The present research question is whether home-based tDCS is an effective treatment for major depression for adults with major depression.

Participants will be randomised to receive either a 10-week course of active tDCS treatment in addition to their standard care (Treatment as Usual), or to only receive Treatment as Usual. Participants will be followed up for 6-months after the start of the treatment began.

After the 6-month follow-up visit, all participants from both groups can choose to continue/start the tDCS treatment. There will be a final follow-up visit 3 months later (9 months from the original treatment start of the trial).

Conditions

• Major Depressive Disorder (MDD)

Interventions

DEVICE

transcranial direct current stimulation (tDCS)

Participants randomised to the tDCS treatment arm will use a tDCS device which is a headset with the anode positioned over left dorsolateral prefrontal cortex (DLPFC) and cathode over right DLPFC (EEG positions F3 and F4, respectively). Treatment protocol consists of 5 tDCS sessions per week for 3 weeks followed by 3 tDCS sessions per week for 7 weeks, for a total of 36 sessions in 10 weeks. tDCS stimulation is 2 mA for 30 minutes with gradual ramp up over 30 seconds at the start and end of each session.

Sponsors & Collaborators

• Nottinghamshire Healthcare NHS Trust

  collaborator OTHER_GOV

• Cardiff and Vale University Health Board

  collaborator OTHER_GOV

• Northumberland, Tyne and Wear NHS Foundation Trust

  collaborator OTHER

• Northamptonshire Healthcare NHS Foundation Trust

  collaborator OTHER

• South London and Maudsley NHS Foundation Trust

  collaborator OTHER

• Southern Health NHS Foundation Trust

  collaborator OTHER

• King's College London

  lead OTHER

Principal Investigators

• Cynthia Fu, MD, PhD · King's College London

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-18

Primary Completion

2027-05-15

Completion

2027-12-31

Countries

• United Kingdom

Study Locations