Modulation of Cognitive Control by Transcranial Direct Current Stimulation

Major Depression Clinical Trial

Official title:

Modulation of Cognitive Control in Healthy and Depressed Subjects by Transcranial Direct Current Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01652391
• Other study ID #: 211/2010BO1_1
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: December 29, 2013
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Device:
• Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)

Locations

Country	Name	City	State
Germany	Universitiy Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correctness of response		The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).	No
Secondary	Reaction time		The secondary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).	No