An interventional study of anodal transcranial direct current stimulation and transcranial direct current stimulation (sham) in Anodal Stimulation tDCS, Major Depression and Cognitive Control, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-01.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Basic science
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.
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's planned enrollment of 44 is below the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
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Inclusion Criteria for depressed patients
Inclusion Criteria for all participants
Exclusion Criteria:
Exclusion Criteria for healthy participants:
transcranial direct current stimulation of the left dlPFC with 1mA
Device: anodal transcranial direct current stimulation
Double blind sham stimulation (stimulation will be ramped down after 30 sec.)
Device: transcranial direct current stimulation (sham)
Also known as: anodal tDCS
for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down.
Also known as: sham tDCS
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: in two sessions through study completion, on average 10 days
Plan to share: No
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This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen