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Effects of tDCS-enhanced Cognitive Control Training on Depression

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ClinicalTrials.gov Identifier: NCT03518749
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : February 19, 2019
Sponsor:
Collaborators:
German Federal Ministry of Education and Research
Universität Tübingen
Information provided by (Responsible Party):
University Hospital Tuebingen

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).


Condition or disease Intervention/treatment Phase
Depression Unipolar Other: 1mA tDCS Other: 2mA tDCS Behavioral: Cognitive control training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of tDCS-enhanced Cognitive Control Training on Depression
Actual Study Start Date : March 19, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: 1mA tDCS
transcranial direct current stimulation with the intensity of 1mA

Behavioral: Cognitive control training
cognitive control training with the PASAT

Active Comparator: 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.
Other: 2mA tDCS
transcranial direct current stimulation with the intensity of 2mA

Behavioral: Cognitive control training
cognitive control training with the PASAT

Placebo Comparator: 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.
Behavioral: Cognitive control training
cognitive control training with the PASAT




Primary Outcome Measures :
  1. Change of MADRS scores [ Time Frame: Assessment one week before training start (week -1, day -5 on average) and in the last training session (week 4, day 26) ]
    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


Secondary Outcome Measures :
  1. BDI scores [ Time Frame: 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) ]
    Beck Depression Inventory

  2. Number of correct trials in the PASAT [ Time Frame: 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) ]
    Performance in the PASAT. Number of correct trials.

  3. RT in the DWM [ Time Frame: 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) ]
    Reaction time in the transfer task, a delayed working memory task (DWM)

  4. Number of correct trials in the DWM [ Time Frame: 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 transfer task, a delayed working memory task (DWM)

  5. GAF score [ Time Frame: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average) ]
    Global Assessment of Functioning

  6. Delta Mood ratings [ Time Frame: 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) ]
    Mood changes (PANAS delta) through the PASAT performance: the positive and negative affective schedule (PANAS) will be conducted immediately before and after the PASAT performance. The change in mood ratings (PANAS delta = PANAS pre PASAT - PANAS post PASAT) will be the outcome measure.

  7. Subjective performance ratings [ Time Frame: 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) ]
    Participants will be asked to rate their performance and overall cognitive abilities on a likert scale.

  8. Electroencephalography (EEG) measures [ Time Frame: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average) ]
    EEG will be conducted to measure resting state oscillations and event related potentials stimulus locked to the presented feedback in the PASAT

  9. Prefrontal Brain activity (NIRS) [ Time Frame: Assessment one week before training start (week -1, day -5 on average) and in the post training session (week 5, day 31 on average) ]
    Functional Near Infrared Spectroscopy will be used to measure frontal brain activity: resting state and during task performance.

  10. Course of MADRS scores [ Time Frame: Assessment once a week during training (week 1, 2 and 3 at day 5, 12 and 19 respectively on average) and at the follow up visits (week 5 and 17, day 31 and 110 on average) ]
    Depressive Symptom severity will be measured with the Montgomery-Åsberg Depression Rating Scale

  11. Prefrontal Brain activity (NIRS) as a predictor [ Time Frame: Assessment one week before training start (week -1, day -5 on average) ]
    The investigators will analyze if frontal brain activity measured with NIRS during resting state and task performance can contribute to the prediction of the effectiveness of the tDCS training.

  12. Electroencephalography (EEG) measures as a predictor [ Time Frame: Assessment one week before training start (week -1, day -5 on average) ]
    The investigators will analyze if resting state oscillations and event related potentials stimulus locked to the presented feedback in the PASAT can contribute to the prediction of the effectiveness of the tDCS training.

  13. Genetic factors as predictors [ Time Frame: Assessment one week before training start (week -1, day -5 on average) ]
    The investigators will analyze if genetic factors involved in neuroplasticity (5-HTTLPR, BDNF, COMT) can contribute to the prediction of the effectiveness of the tDCS training.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • current Major Depressive Episode
  • right handedness

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518749


Contacts
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Contact: Christian Plewnia, MD +49 (0)7071-2986121 christian.plewnia@uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen Recruiting
Tubingen, Baden-Württemberg, Germany, 72076
Contact: Christian Plewnia, Prof., MD    0049 7071 29 86121    christian.plewnia@uni-tuebingen.de   
Contact: Anja Sommer, M.Sc.    0049 7071 29 86127    anja.sommer@med.uni-tuebingen.de   
Principal Investigator: Christian Plewnia, Prof., MD         
Sponsors and Collaborators
University Hospital Tuebingen
German Federal Ministry of Education and Research
Universität Tübingen

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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03518749     History of Changes
Other Study ID Numbers: 01EE1403D-2
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
Depression
transcranial direct current stimulation (tDCS)
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders