Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients

January 30, 2017 updated by: University Hospital Tuebingen

The Effect of Transcranial Direct Current Stimulation (tDCS) on Cognitive Control and Emotion Regulation in Depressed Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Working hypothesis: anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) can enhance healthy and impaired cognitive control (CC) and reduce the use of dysfunctional emotion regulation strategies.
  2. Previous work of the investigators: The investigators previous work has provided decisive evidence for polarity-specific activity-dependent effects of tDCS to the left dlPFC on cognitive planning and control of emotional information processing in healthy subjects and patients with MD. Particularly, reduced prefrontal brain activity during a working memory task in patients with MD was found by using near infrared spectroscopy (NIRS). In addition, the investigators demonstrated that a single session, anodal, activity enhancing tDCS to the left dlPFC ameliorates deficient CC in patients with depression, whereas cathodal, activity reducing tDCS, induces a depression-like negativity bias in healthy subjects. Furthermore, the investigators showed that during anodal tDCS of the left dlPFC healthy subjects showed (a) better performance in a CC task (b) no increase in angry mood after the task compared to a control group and (c) that elevated angry mood was associated to a worse performance in the CC task.
  3. Aims and workplan: to investigate the effects of anodal tDCS of the left dLPFC in healthy and depressed subjects the investigators will conduct a double-blind, randomized, sham-controlled, cross-over design. In two sessions each participant (22 depressed and 22 healthy subjects, N= 44) will complete a CC task while receiving anodal tDCS (1 mA) to the left dlPFC in one session and sham 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.

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Tubingen, Baden-Württemberg, Germany, 72076
        • Recruiting
        • University Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for depressed patients

  • diagnosed major depression (DSM-V)
  • stable medication for four weeks

Inclusion Criteria for all participants

  • right handedness

Exclusion Criteria:

  • history of seizures
  • metal device throughout the body
  • pregnancy
  • use of von antipsychotics / mood stabilizer
  • diagnosed bipolar disorder
  • current substance abuse (nicotine excluded)
  • diagnosed psychotic diseases
  • diagnosed anorexia nervosa
  • diagnosed personality disorders: cluster A, antisocial personality disorder, borderline personality disorder

Exclusion Criteria for healthy participants:

  • history of affective disorders or current affective disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: anodal tDCS
transcranial direct current stimulation of the left dlPFC with 1mA
Device: anodal transcranial direct current stimulation
Other Names:
  • anodal tDCS
PLACEBO_COMPARATOR: Sham stimulation
Double blind sham stimulation (stimulation will be ramped down after 30 sec.)
Device: transcranial direct current stimulation (sham)
for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down.
Other Names:
  • sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interstimulusintervall and number of correct trials in the PASAT
Time Frame: Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days.
To measure the performance in the PASAT the number of correct trials as well as the mean Interstimulusintervall will be assessed.
Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days.
Change of positive and negative affect
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.
Change of positive and negative affect after, compared to before performing the PASAT and also change of the affect during the resting phase.
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
Time Frame: in two sessions through study completion, on average 10 days
The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect.
in two sessions through study completion, on average 10 days
Score in state rumination questionnaire
Time Frame: in two sessions through study completion, on average 10 days
The state rumination will be measured after the resting phase
in two sessions through study completion, on average 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

German Federal Ministry of Education and Research
Universität Tübingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

January 30, 2017

First Posted (ESTIMATE)

February 1, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01EE1403D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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