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Modulation of Cognitive Control by Transcranial Direct Current Stimulation

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Major Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitiy Hospital Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anodal transcranial direct current stimulation

Sham transcranial direct current stimulation

Arm Description

Anodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus

Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus

Outcomes

Primary Outcome Measures

Correctness of response

Secondary Outcome Measures

Reaction time

Full Information

First Posted
July 23, 2012
Last Updated
December 29, 2013
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT01652391
Brief Title
Modulation of Cognitive Control by Transcranial Direct Current Stimulation
Official Title
Modulation of Cognitive Control in Healthy and Depressed Subjects by Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Anodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus
Arm Title
Sham transcranial direct current stimulation
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)
Primary Outcome Measure Information:
Title
Correctness of response
Time Frame
The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).
Secondary Outcome Measure Information:
Title
Reaction time
Time Frame
The secondary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Universitiy Hospital Tübingen
City
Tübingen
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23219367
Citation
Wolkenstein L, Plewnia C. Amelioration of cognitive control in depression by transcranial direct current stimulation. Biol Psychiatry. 2013 Apr 1;73(7):646-51. doi: 10.1016/j.biopsych.2012.10.010. Epub 2012 Dec 6.
Results Reference
derived

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Modulation of Cognitive Control by Transcranial Direct Current Stimulation

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