Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients
The Effect of Transcranial Direct Current Stimulation (tDCS) on Cognitive Control and Emotion Regulation in Depressed Patients
1 other identifier
interventional
44
1 country
1
Brief Summary
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.
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 Sep 2016
Shorter than P25 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
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedFebruary 1, 2017
August 1, 2016
7 months
October 28, 2016
January 30, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Interstimulusintervall and number of correct trials in the PASAT
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
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
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
The state rumination will be measured after the resting phase
in two sessions through study completion, on average 10 days
Study Arms (2)
anodal tDCS
ACTIVE COMPARATORtranscranial direct current stimulation of the left dlPFC with 1mA
Sham stimulation
PLACEBO COMPARATORDouble blind sham stimulation (stimulation will be ramped down after 30 sec.)
Interventions
for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down.
Eligibility Criteria
You may qualify if:
- diagnosed major depression (DSM-V)
- stable medication for four weeks
- right handedness
You may not qualify if:
- 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
- history of affective disorders or current affective 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
February 1, 2017
Study Start
September 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
February 1, 2017
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share