Transcranial Direct Current Stimulation Therapy for Bipolar Depression

Bipolar Disorder Clinical Trial

Official title:

Community-based Transcranial Direct Current Stimulation Treatment for Bipolar Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05436613
• Other study ID #: 308690
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: University of East London
• Contact: Cynthia Fu, MD, PhD
• Phone: 0208 223 4119
• Email: C.Fu[@]uel.ac.uk
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of bipolar disorder based on DSM-5 criteria
• minimum score of 18 on the MADRS
• being on a stable dosage of mood stabilizing medication for a minimum of two weeks

Exclusion Criteria:

• comorbid psychiatric disorder
• significant risk of suicide or self harm
• any contraindications to tDCS, including implanted electronic medical devices
• history of epilepsy

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder
• Mental Disorder
• Mental Disorders
• Mood Disorders

Intervention

Device:
• Transcranial Direct Current Stimulation
tDCS at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks.

Locations

Country	Name	City	State
United Kingdom	University of East London	London

Sponsors (4)

Lead Sponsor	Collaborator
University of East London	King's College London, Technische Universität Dresden, University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Mutz J, Edgcumbe DR, Brunoni AR, Fu CHY. Efficacy and acceptability of non-invasive brain stimulation for the treatment of adult unipolar and bipolar depression: A systematic review and meta-analysis of randomised sham-controlled trials. Neurosci Biobehav Rev. 2018 Sep;92:291-303. doi: 10.1016/j.neubiorev.2018.05.015. Epub 2018 May 12. — View Citation

Mutz J, Vipulananthan V, Carter B, Hurlemann R, Fu CHY, Young AH. Comparative efficacy and acceptability of non-surgical brain stimulation for the acute treatment of major depressive episodes in adults: systematic review and network meta-analysis. BMJ. 2019 Mar 27;364:l1079. doi: 10.1136/bmj.l1079. — View Citation

Woodham R, Rimmer RM, Mutz J, Fu CHY. Is tDCS a potential first line treatment for major depression? Int Rev Psychiatry. 2021 May;33(3):250-265. doi: 10.1080/09540261.2021.1879030. Epub 2021 Mar 11. — View Citation

Woodham RD, Rimmer RM, Young AH, Fu CHY. 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. J Psychiatr Res. 2022 Sep;153:197-205. doi: 10.1016/j.jpsychires.2022.07.026. Epub 2022 Jul 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response [ Time Frame: At 6 weeks following course of tDCS treatment ]	As measured by clinician-rated MADRS score improvement of >= 50% following the course of tDCS treatment	6 weeks