NCT01903538

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 a decrease of dlPFC activity in healthy subjects by cathodal 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 of cathodal tDCS to the left dlPFC on cognitive control in healthy subjects. To assess the cognitive control the investigators use a delayed response working memory task (DWM)and an arithmetic inhibition task (AIT) with pictures of varying valence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

July 13, 2013

Last Update Submit

July 16, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correctness and reaction time of response

    Correctness is defined as the percentage of correct responses in the DWM and AIT

    Within 30 min starting 5 min after the initiation of stimulation

Study Arms (2)

Cathodal transcranial direct current stimulation

EXPERIMENTAL
Device: Cathodal transcranial direct current stimulation (tDCS)

Sham transcranial direct current stimulation

SHAM COMPARATOR
Device: Sham transcranial direct current stimulation

Interventions

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

Cathodal transcranial direct current stimulation

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

Sham transcranial direct current stimulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • informed consent

You may not qualify if:

  • psychiatric or neurological disorders seizures cardiac pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Tübingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2013

First Posted

July 19, 2013

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 19, 2013

Record last verified: 2013-07

Locations