Modulation of Cognitive Control by Transcranial Direct Current Stimulation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Plewnia, MD, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01652391
First received: July 23, 2012
Last updated: December 29, 2013
Last verified: December 2013
  Purpose

Insufficient cognitive control over emotional distracters is characteristic for major depressive disorder (MDD). Hypoactivation of the dorsolateral prefrontal cortex (dlPFC) is associated with this deficit. In this study the investigators assess the effect of an enhancement of dlPFC activity in MDD patients by anodal transcranial direct current stimulation (tDCS) on cognitive control.

In a double-blinded, balanced randomized, sham-controlled crossover trial the investigators determine the effect of a single-session tDCS to the left dlPFC on cognitive control in MDD patients and healthy controls. To assess the cognitive control the investigators use a delayed response working memory (DWM) task with pictures of varying valence presented during the delay period.


Condition Intervention
Major Depression
Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Modulation of Cognitive Control in Healthy and Depressed Subjects by Transcranial Direct Current Stimulation

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Correctness of response [ Time Frame: The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reaction time [ Time Frame: The secondary outcome measure is obtained during the intervention (20min tDCS or sham stimulation). ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: July 2011
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anodal transcranial direct current stimulation
Anodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus
Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)
Sham Comparator: Sham transcranial direct current stimulation
Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus
Device: Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age > 18
  • informed consent
  • in the patients group: Major depressive disorder, no antidepressant medication or stability over 1 week

Exclusion Criteria:

  • seizures
  • cardiac pacemaker
  • deep brain stimulation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652391

Locations
Germany
Universitiy Hospital Tübingen
Tübingen, Germany
Sponsors and Collaborators
University Hospital Tuebingen
  More Information

No publications provided by University Hospital Tuebingen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Plewnia, MD, Professer, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01652391     History of Changes
Other Study ID Numbers: 211/2010BO1_1
Study First Received: July 23, 2012
Last Updated: December 29, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Depression
Depressive Disorder, Major
Behavioral Symptoms
Depressive Disorder
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 22, 2014