Effects of tDCS-enhanced Cognitive Control Training on Depression
1 other identifier
interventional
57
1 country
1
Brief Summary
Deficient cognitive control (CC) is one of the central characteristics of major depression (MD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) has been linked with this deficit. Antidepressants and cognitive-behavioral therapies modify CC most-likely as a common mechanism of treatment. Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. It has been shown, that the activity of the dlPFC can be modulated by transcranial direct current stimulation (tDCS) with polarity-dependent learning-phase specific effects on performance that, when combined with training, can outlast the stimulation. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 19, 2018
CompletedFirst Submitted
Initial submission to the registry
April 13, 2018
CompletedFirst Posted
Study publicly available on registry
May 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 19, 2019
February 1, 2019
1.5 years
April 13, 2018
February 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of MADRS scores
Change in Depressive Symptom severity will be measured with the Montgomery-Åsberg Depression Rating Scale (MADRS) from Baseline session to the last stimulation session, scale range from 0 to 60 points, higher scores indicate a more severe depression
Assessment one week before training start (week -1, day -5 on average) and in the last training session (week 4, day 26)
Secondary Outcomes (13)
BDI scores
Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Number of correct trials in the PASAT
Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
RT in the DWM
Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
Number of correct trials in the DWM
Assessment one week before training start (week -1, day -5 on average), in the post training session (week 5, day 31 on average) and at follow-up (week 17, day 110 on average)
GAF score
Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average)
- +8 more secondary outcomes
Study Arms (3)
1mA anodal tDCS + cognitive control training
ACTIVE COMPARATOR1 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training.
2mA tDCS + cognitive control training
ACTIVE COMPARATOR2 mA anodal tDCS will be administered to the left dlPFC (F3) for 23 mins during the performance of a cognitive control training.
sham tDCS + cognitive control training
PLACEBO COMPARATORSham tDCS (30 secs of tDCS) will be administered to the left dlPFC (F3) with 2mA at the beginning of a cognitive control training.
Interventions
transcranial direct current stimulation with the intensity of 1mA
transcranial direct current stimulation with the intensity of 2mA
cognitive control training with the PASAT
Eligibility Criteria
You may qualify if:
- current Major Depressive Episode
- right handedness
You may not qualify if:
- history of seizures
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Tuebingenlead
- German Federal Ministry of Education and Researchcollaborator
- Universität Tübingencollaborator
Study Sites (1)
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Related Publications (1)
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.
PMID: 34812928DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2018
First Posted
May 8, 2018
Study Start
March 19, 2018
Primary Completion
October 1, 2019
Study Completion
December 31, 2019
Last Updated
February 19, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share