Transcranial Direct Current Stimulation Therapy for Major Depression
Keywords
Abstract
Description
The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for major depression. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are 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 study research question is whether tDCS could be provided as a home-based treatment for major depression. The study will include adults with major depression.
Dates
| Last Verified: | 02/29/2020 |
| First Submitted: | 08/07/2018 |
| Estimated Enrollment Submitted: | 08/13/2018 |
| First Posted: | 08/14/2018 |
| Last Update Submitted: | 03/09/2020 |
| Last Update Posted: | 03/11/2020 |
| Actual Study Start Date: | 10/13/2019 |
| Estimated Primary Completion Date: | 05/31/2021 |
| Estimated Study Completion Date: | 10/31/2021 |
Condition or disease
Intervention/treatment
Device: tDCS
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: tDCS 6-week course of active tDCS treatment, consisting of 5 sessions per week for the first 3 weeks followed by 2 sessions per week for 3 weeks, for a total of 21 tDCS sessions. The duration of each session is 30 minutes. | Device: tDCS tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - diagnosis of major depressive disorder based on DSM-5 criteria - minimum score of 16 on Hamilton Rating Scale for Depression (HAM-D) Exclusion Criteria: - history of treatment-resistant depression - comorbid psychiatric disorder - significant risk of suicide or self harm - any contraindications to tDCS, including implanted electronic medical devices |
Outcome
Primary Outcome Measures
1. Clinical response [At 6 weeks following course of tDCS treatment]
