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| Name | Class |
|---|---|
| University College, London | OTHER |
| King's College London | OTHER |
| Technische Universität Dresden | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: transcranial direct current stimulation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | tDCS at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ] | As measured by clinician-rated Montgomery Asberg Depression Rating Scale (MADRS) score improvement of 50% or more from baseline following the course of tDCS treatment. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Retention at the End of the Treatment | The number of participants who have completed a minimum of 15 tDCS sessions | 6 weeks (visit 21) |
| Participant Acceptability Questionnaire Scales |
| Measure | Description | Time Frame |
|---|---|---|
| MADRS Remission Rate | Trained rater measure of depressive symptoms: Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate: a score of less than 10 following the course of tDCS | 6 weeks (Visit 21) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Fu, MD, PhD | University of East London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of East London | London | E16 2RD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29763711 | Background | 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. | |
| 30917990 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device: Transcranial Direct Current Stimulation | 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 at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Device: Transcranial Direct Current Stimulation | 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 at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ] | As measured by clinician-rated Montgomery Asberg Depression Rating Scale (MADRS) score improvement of 50% or more from baseline following the course of tDCS treatment. | Intention to Treat analysis including all participants who enrolled | Posted | Count of Participants | Participants | 6 weeks |
|
6 weeks
Adverse events reported during the trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device: Transcranial Direct Current Stimulation | 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 at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Throat Infection | Immune system disorders | Systematic Assessment | Requiring hospitalisation not related to the study intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Cynthia Fu | University of East Lonson | 020 8223 4119 | c.fu@uel.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2023 | Jun 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Participants were asked how acceptable they found the tDCS treatment after the 6-week course of treatment. They were given responses on a 7-point Likert style scale. The number of participants who rated the tDCS treatment as acceptable on the Treatment Acceptability Questionnaire (Likert responses 5, 6 or 7) are reported.
| Week 6 (Visit 21) |
| 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. |
| 33706656 | Background | 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. |
| 35839661 | Background | 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. |
| 40420071 | Derived | Rezaei H, Woodham RD, Ghazi-Noori AR, Ritter P, Bauer M, Young AH, Bramon E, Fu CHY. Acceptability of home-based transcranial direct current stimulation (tDCS) in bipolar depression: thematic analysis of individual views. BMC Psychiatry. 2025 May 26;25(1):549. doi: 10.1186/s12888-025-06948-4. |
| 40321750 | Derived | Rezaei H, Woodham RD, Ghazi-Noori AR, Ritter P, Bauer M, Young AH, Bramon E, Fu CHY. Acceptability of Home-Based Transcranial Direct Current Stimulation (tDCS) in Bipolar Depression: Thematic Analysis of Individual Views. Res Sq [Preprint]. 2025 Apr 15:rs.3.rs-5967699. doi: 10.21203/rs.3.rs-5967699/v1. |
| 39162912 | Derived | Ghazi-Noori AR, Woodham RD, Rezaei H, Sharif MS, Bramon E, Ritter P, Bauer M, Young AH, Fu CHY. Home-based transcranial direct current stimulation in bipolar depression: an open-label treatment study of clinical outcomes, acceptability and adverse events. Int J Bipolar Disord. 2024 Aug 20;12(1):30. doi: 10.1186/s40345-024-00352-9. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ammons Quick Test (measure of IQ) | The Ammons Quick Test is a measure of receptive vocabulary, verbal intelligence, and verbal information processing. Range of scores representing Intelligence Quotient (IQ) - 40 to 135. Higher values indicate higher IQ, or greater intelligence. | Mean | Standard Deviation | units on a scale |
|
| MADRS: Montgomery-Åsberg Depression Rating Scale | MADRS is a clinician rated diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Range of scores: 0 to 60. Higher scores represent greater severity of depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| HDRS-17: Hamilton Depression Rating Scale | HDRS-17 is a clinician rated diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Range of scores: 0 to 52. Higher scores represent greater severity of depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| HAMA: Hamilton Anxiety Rating Scale | HAMA is a clinician rated diagnostic questionnaire used to measure the severity of anxiety symptoms in patients with mood disorders. Range of scores: 0 to 56. Higher scores represent greater severity of anxiety symptoms. | Mean | Standard Deviation | units on a scale |
|
| YMRS: Young Mania Rating Scale | YMRS is a clinician rated diagnostic questionnaire used to measure the severity of manic symptoms in patients with mood disorders. Range of scores: 0 to 60. Higher scores represent greater severity of manic symptoms. | Mean | Standard Deviation | units on a scale |
|
| PHQ-9: Patient Health Questionnaire-9 | PHQ-9 is a self-reported diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Range of scores: 0 to 27. Higher scores represent greater severity of depressive symptoms. | Mean | Standard Deviation | units on a scale |
|
| SDS: Sheehan Disability Scale | SDS is a brief, self -report questionnaire designed to assess functional impairment caused by psychiatric or medical symptoms across three key life domains: work/school, social life/leisure activities, and family life/home responsibilities. Scores range from 0 to 30 with higher scores indicating greater functional impairment. | Mean | Standard Deviation | units on a scale |
|
|
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| Secondary | Participant Retention at the End of the Treatment | The number of participants who have completed a minimum of 15 tDCS sessions | Posted | Count of Participants | Participants | 6 weeks (visit 21) |
|
|
|
| Secondary | Participant Acceptability Questionnaire Scales | Participants were asked how acceptable they found the tDCS treatment after the 6-week course of treatment. They were given responses on a 7-point Likert style scale. The number of participants who rated the tDCS treatment as acceptable on the Treatment Acceptability Questionnaire (Likert responses 5, 6 or 7) are reported. | Posted | Count of Participants | Participants | Week 6 (Visit 21) |
|
|
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| Other Pre-specified | MADRS Remission Rate | Trained rater measure of depressive symptoms: Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate: a score of less than 10 following the course of tDCS | Posted | Count of Participants | Participants | 6 weeks (Visit 21) |
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| 0 |
| 44 |
| 1 |
| 44 |
| 43 |
| 44 |
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| Scalp pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Trouble concentrating | Nervous system disorders | Systematic Assessment |
|
| Sleepiness | Nervous system disorders | Systematic Assessment |
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| Acute mood change | Nervous system disorders | Systematic Assessment |
|
| Sore feeling at electrode site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dizziness | Ear and labyrinth disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |