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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| Universität Tübingen | OTHER |
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Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies (ERS) are both central characteristics of major depression. Both are associated with reduced activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. The goal of this randomized, sham-controlled, double blind clinical trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC and ERS in depressed patients compared to healthy subjects. Overall, the study will include 44 participants (22 depressed Patients and 22 healthy subjects). Each participant will complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting phase by means of a questionnaire and psychophysiological measures (heart rate variability). The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this experiment will provide new and reliable data for the development of new treatment methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anodal tDCS | Active Comparator | transcranial direct current stimulation of the left dlPFC with 1mA |
|
| Sham stimulation | Placebo Comparator | Double blind sham stimulation (stimulation will be ramped down after 30 sec.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anodal transcranial direct current stimulation | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Interstimulusintervall and number of correct trials in the PASAT | To measure the performance in the PASAT the number of correct trials as well as the mean Interstimulusintervall will be assessed. | Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days. |
| Change of positive and negative affect | Change of positive and negative affect after, compared to before performing the PASAT and also change of the affect during the resting phase. | The positive and negative affect is assessed (a) right before and after the PASAT in two sessions through study completion, on average 10 days. And (b) also after the resting phase in two sessions through study completion, on average 10 days. |
| Heart rate variability | The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect. | in two sessions through study completion, on average 10 days |
| Score in state rumination questionnaire | The state rumination will be measured after the resting phase | in two sessions through study completion, on average 10 days |
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Inclusion Criteria for depressed patients
Inclusion Criteria for all participants
Exclusion Criteria:
Exclusion Criteria for healthy participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Plewnia, MD | Contact | +49 (0)7071-2986121 | christian.plewnia@uni-tuebingen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Recruiting | Tübingen | Baden-Wurttemberg | 72076 | Germany |
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| transcranial direct current stimulation (sham) |
| Device |
for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down. |
|
|
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D000080103 | Emotional Regulation |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
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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 |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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