- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01652391
Modulation of Cognitive Control by Transcranial Direct Current Stimulation
Modulation of Cognitive Control in Healthy and Depressed Subjects by Transcranial Direct Current Stimulation
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tübingen, Germany
- Universitiy Hospital Tübingen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Anodal transcranial direct current stimulation
Anodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus
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Sham Comparator: Sham transcranial direct current stimulation
Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correctness of response
Time Frame: The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).
|
The primary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reaction time
Time Frame: The secondary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).
|
The secondary outcome measure is obtained during the intervention (20min tDCS or sham stimulation).
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 211/2010BO1_1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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