Transcranial Direct Current Stimulation Therapy for Major Depression
NCT ID: NCT03632434
Last Updated: 2024-08-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2019-10-14
2021-11-26
Brief Summary
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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 tDCS can be provided as a home-based treatment for major depression for adults with major depression.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active 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.
transcranial direct current stimulation
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.
Interventions
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transcranial direct current stimulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* minimum score of 16 on Hamilton Rating Scale for Depression (HAM-D)
Exclusion Criteria
* comorbid psychiatric disorder
* significant risk of suicide or self harm
* any contraindications to tDCS, including implanted electronic medical devices
18 Years
ALL
No
Sponsors
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Rosetrees Trust
OTHER
King's College London
OTHER
University College, London
OTHER
University of Oxford
OTHER
University of East London
OTHER
Responsible Party
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Cynthia Fu
College Professor of Affective Neuroscience
Principal Investigators
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Cynthia Fu, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of East London
Locations
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University of East London
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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A1950
Identifier Type: -
Identifier Source: org_study_id
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