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A randomized, controlled three-arm study is planned to investigate the effectiveness and feasibility of an accelerated home-based tDCS application (3 weeks of transcranial direct current stimulation at home, twice daily). A total of 30 patients with depression (10 per group), who are currently not taking and have no history of taking antidepressant medication, will be randomly assigned to either an active tDCS condition, a sham (placebo) tDCS condition, or a waitlist control group. The latter two groups will receive active tDCS treatment after completion of the control phase.
This study represents a continuation of the pilot study GSUND DAHOAM (Ethics approval: 20-2091-101; Dragon et al., 2024).
The aim of this study is to evaluate the feasibility of home-based tDCS for the accelerated treatment (twice daily) of depressive disorders (GSUND DAHOAM 2.0 = continuation of the study "GleichStrom UND Depression: Anwendung zu Hause Ohne Anreise zur Medbo"; Dragon et al., 2024).
Specifically, the study will assess feasibility (device usability, patient compliance, and usability of the video consultation), effectiveness (clinical ratings), and tolerability of this intervention in 30 patients with depression. Participants will be randomly assigned to one of three groups: active tDCS treatment, sham (placebo) tDCS treatment, or a waitlist control group (waiting period: 3 weeks). The latter two groups will subsequently receive active tDCS treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum accelerated home-based tDCS | Experimental | 10 patients will receive active tDCS during a three-week intervention (accelerated: twice daily). |
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| Sham accelerated home-based tDCS | Placebo Comparator | 10 patients will receive sham tDCS during a three-week intervention (accelerated: twice daily) with the opportunity to get active tDCS after study completion. |
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| Waiting list | No Intervention | 10 patients will have to wait for three weeks before the beginning ot the active tDCS intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation | Device | Non-invasive brain stimulation techniques, such as transcranial direct current stimulation (tDCS), have gained increasing attention in recent years in both research and the treatment of various psychiatric disorders (Alonzo et al., 2019; Lefaucher et al., 2017). Compared to other neuromodulation methods, such as transcranial magnetic stimulation (TMS), tDCS offers the advantage of mobile or outpatient use, including home-based application. tDCS devices are small, portable, and cost-effective, and they are associated with a favorable side-effect profile (Alonzo et al., 2019). |
| Measure | Description | Time Frame |
|---|---|---|
| Course of the scores of the Hamilton Depression rating scale (21 Items) | Depression rating scale (0-65, the lower the better) | 3 weeks |
| Course of the scores of the Major Depression Inventory | Depression rating scale (0-50, the lower the better) | 3 weeks |
| Compliance | Number of treatments administered (0-30 sessions, the more the better) | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefan Schoisswohl, PD, PhD | Contact | +499419411284 | stefan.schoisswohl@ukr.de | |
| Ulrike Stadler | Contact | +499419411256 | tms-psy-r@medbo.de |
| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth, Prof, PhD | University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatry and Psychotherapy, Center of Neuromodulation / TMS, University Regensburg | Recruiting | Regensburg | Bavaria | 93053 | Germany |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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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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Thirty patients will be randomly assigned to one of three study arms (n = 10 per group): active (verum) tDCS, sham (placebo) tDCS, or a waitlist control group. The latter two groups will subsequently be given the opportunity to receive active tDCS treatment.
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Random allocation to the three groups will be performed by chance.
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| D001519 |
| Behavior |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |