Effects of tDCS-enhanced Cognitive Control Training on Depression

Last updated: February 15, 2019
Sponsor: University Hospital Tuebingen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

N/A

Clinical Study ID

NCT03518749
01EE1403D-2
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • current Major Depressive Episode

  • right handedness

Exclusion

Exclusion Criteria:

  • history of seizures

  • Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, orelectrodes) 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

Study Design

Total Participants: 57
Study Start date:
March 19, 2018
Estimated Completion Date:
December 31, 2019

Connect with a study center

  • University Hospital Tuebingen

    Tubingen, Baden-Württemberg 72076
    Germany

    Active - Recruiting

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