Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07556692

Home-based Transcranial Direct Current Stimulation to Treat Bipolar Depression: A Randomised, Double-blind, Placebo-controlled Trial

Led by King's College London · Updated on 2026-04-29

212

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

K

King's College London

Lead Sponsor

S

South London and Maudsley NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Bipolar depression is a persistent and disabling condition where many people continue to have depressive symptoms despite standard treatments. Researchers are evaluating whether a home-based transcranial direct current stimulation (tDCS) device is effective and safe in reducing symptoms of bipolar depression compared to a placebo (sham) treatment. The study also explores how acceptable the treatment is to participants and how well they can use the device at home. Participants will be randomly assigned to use either an active tDCS device or a sham (placebo) device at home over a 10-week treatment period. The device used is the Flow FL-100 tDCS headset, which delivers a low-intensity electrical current to the brain's dorsolateral prefrontal cortex. This is a portable device that participants will self-administer, with neither they nor the researchers knowing which treatment they receive during the trial. During the study, participants will complete scheduled assessments including clinician interviews and self-reported questionnaires on mood and well-being. Device usage and adherence will be electronically monitored. Participants will be followed for 6 months after treatment to assess effects on depressive and anxiety symptoms, as well as quality of life. Safety and any side effects such as mild tingling or skin irritation will be closely monitored throughout the study, which primarily takes place remotely from participants' homes.

CONDITIONS

Brief Title

A Study of Home-use Brain Stimulation to Treat Bipolar Depression

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or over
  • Diagnosis of bipolar disorder currently in a depressive episode based on DSM-5 criteria assessed by a structured clinical interview
  • Moderate or more severe depressive symptoms with a MADRS score of at least 18
  • Either not taking antidepressant medication or on a stable dose for at least 6 weeks before joining
  • Either not currently in psychotherapy or in psychotherapy for at least 6 weeks before joining
  • Under care of a general practitioner (GP)
  • Agree to have GP regularly informed about study participation
  • Able to provide written, informed consent
Not Eligible

You will not qualify if you...

  • Significant suicide risk based on specific screening questions
  • Primary comorbid psychiatric disorders such as obsessive compulsive disorder
  • High mania symptoms with Young Mania Rating Scale score of 20 or more
  • Daily use of medications affecting brain excitability like benzodiazepines
  • Current illicit drug use or heavy alcohol use with high risk of disorder
  • History of brain stimulation treatments or psychosurgery for depression
  • History of esketamine or ketamine treatment for depression
  • Medical disorders that may mimic mood disorders
  • History of heart problems such as heart attack or heart failure
  • Cognitive impairment such as dementia
  • History of neurological disorders like stroke, seizures, or Parkinson's disease
  • History of migraines or severe headaches
  • Brain implants, skull defects, or active medical implants
  • Presence of shrapnel or metal in the head
  • Females of child-bearing potential who are pregnant or planning pregnancy during the study
  • Currently enrolled in another interventional study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 10 weeks

Participants receive a 10-week course of home-based transcranial direct current stimulation (tDCS) using the Flow FL-100 headset, alongside their usual treatment for bipolar depression.

Weekly visits for up to 10 weeks

Follow-up

Duration - 6 months post randomisation

Participants are assessed at 6 months after randomisation to evaluate longer-term effects on depressive and anxiety symptoms, as well as quality of life.

1 follow-up visit (in-person or remote)

Trial Site Locations

Total: 1 location

1

South London and Maudsley NHS Foundation Trust

London, United Kingdom

Actively Recruiting

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Research Team

P

Professor Cynthia Fu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Acceptability of active and sham home-based transcranial direct current stimulation in major depression: mixed methods qualitative analysis in a randomised controlled trial.

Peter J Lagerberg, Rachel D Woodham, Sudhakar Selvaraj...

https://pubmed.ncbi.nlm.nih.gov/41345653

Acceptability of home-based transcranial direct current stimulation (tDCS) in bipolar depression: thematic analysis of individual views.

Hakimeh Rezaei, Rachel D Woodham, Ali-Reza Ghazi-Noori...

https://pubmed.ncbi.nlm.nih.gov/40420071

Home-based transcranial direct current stimulation in bipolar depression: an open-label treatment study of clinical outcomes, acceptability and adverse events.

Ali-Reza Ghazi-Noori, Rachel D Woodham, Hakimeh Rezaei...

https://pubmed.ncbi.nlm.nih.gov/39162912

Home-based transcranial direct current stimulation for major depressive disorder: 6-month follow-up from randomised sham-controlled trial and open-label treatment phases.

Rachel D Woodham, Sudhakar Selvaraj, Nahed Lajmi...

https://pubmed.ncbi.nlm.nih.gov/40209536

Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial.

Rachel D Woodham, Sudhakar Selvaraj, Nahed Lajmi...

https://pubmed.ncbi.nlm.nih.gov/39433921

Adjunctive home-based transcranial direct current stimulation treatment for major depression with real-time remote supervision: An open-label, single-arm feasibility study with long term outcomes.

Rachel D Woodham, Rachael M Rimmer, Allan H Young...

https://pubmed.ncbi.nlm.nih.gov/35839661