Effects of tDCS-enhanced Cognitive Control Training on Depression
NCT ID: NCT03518749
Last Updated: 2019-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
57 participants
INTERVENTIONAL
2018-03-19
2019-12-31
Brief Summary
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The goal of this randomized, sham-controlled, rater blind clinical trial is to investigate the effect of a tDCS-enhanced CC Training (CCT) on depressive symptom severity and compare the stimulation intensities 1mA, 2mA and sham tDCS. Overall, the study will include 57 participants (n = 19 per group). Each participant will complete 12 training sessions with online sham/ anodal tDCS.
As a training task we will use an adaptive version of the paced auditory serial addition task (PASAT). In the PASAT, digits are presented auditive and participants have to add the current digit to the digit they heard before. In the adaptive version the interstimulus-intervals decrease (increase) when four consecutive trials are correct (incorrect). The PASAT is known to elicit frustration. Participants have to exert cognitive control over these emotions to complete the task successfully.
Before, during and after the training symptom severity will be assessed. Baseline and post-training performance in the PASAT and in a transfer task (delayed working memory task, DWM) will be measured.
To further explore variables that influence the effect of tDCS on depressive symptom severity we will measure brain activity (EEG, NIRS), heart rate, global functioning (GAF), emotion regulation strategies, self-esteem, mood ratings and subjective performance ratings before and after the training and collect genetic factors.
Sustainability of the training effects will be measured at a follow-up visit (3 months later).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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1mA anodal tDCS + cognitive control training
1 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training.
1mA tDCS
transcranial direct current stimulation with the intensity of 1mA
Cognitive control training
cognitive control training with the PASAT
2mA tDCS + cognitive control training
2 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training.
2mA tDCS
transcranial direct current stimulation with the intensity of 2mA
Cognitive control training
cognitive control training with the PASAT
sham tDCS + cognitive control training
Sham tDCS (30 secs of tDCS) will be administered to the left dlPFC (F3) with 2mA at the beginning of a cognitive control training.
Cognitive control training
cognitive control training with the PASAT
Interventions
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1mA tDCS
transcranial direct current stimulation with the intensity of 1mA
2mA tDCS
transcranial direct current stimulation with the intensity of 2mA
Cognitive control training
cognitive control training with the PASAT
Eligibility Criteria
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Inclusion Criteria
* right handedness
Exclusion Criteria
* Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
* pregnancy
* use of mood stabilizers
* diagnosed bipolar disorder
* current substance abuse (nicotine excluded)
* current substance addiction (nicotine excluded)
* diagnosed psychotic diseases
* diagnosed anorexia nervosa
* diagnosed personality disorders: cluster A, antisocial personality disorder,
* borderline personality disorder
18 Years
65 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
Universität Tübingen
OTHER
University Hospital Tuebingen
OTHER
Responsible Party
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Locations
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University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Sommer A, Fallgatter AJ, Plewnia C. Investigating mechanisms of cognitive control training: neural signatures of PASAT performance in depressed patients. J Neural Transm (Vienna). 2022 Jun;129(5-6):649-659. doi: 10.1007/s00702-021-02444-7. Epub 2021 Nov 23.
Other Identifiers
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01EE1403D-2
Identifier Type: -
Identifier Source: org_study_id
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