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Sponsored by: |
Ludwig-Maximilians - University of Munich |
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Information provided by: | Ludwig-Maximilians - University of Munich |
ClinicalTrials.gov Identifier: | NCT00667680 |
tDCS applies a small amount of direct electric current (DC) to the brain by means of two electrodes: the one is an active electrode, localized on the effective site, and the other is a reference electrode, localized on some "silent" part of the body. Anodal transcranial direct current stimulation (tDCS) of the left dorsolateral prefrontal cortex (DLPFC) has been associated with working memory enhancement and improvement of mood. This study will investigate the possible antidepressant effects of tDCS in patients with therapy resistant major depressive episodes.
Condition | Intervention | Phase |
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Therapy Resistant Major Depression |
Device: Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Transcranial Direct Current Stimulation (tDCS) in Treatment-Resistant Depression - Effect on Clinical and Neurophysiological Parameters |
Estimated Enrollment: | 20 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
anodal tDCS
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Device: Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator
real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
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2: Sham Comparator
Sham tDCS
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Device: Transcranial direct current stimulation (tDCS) - Eldith DC-Stimulator
real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system)
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Transcranial direct current stimulation (tDCS) is a non-invasive method that shifts membrane potential towards hypo- or hyperpolarization and therefore leads to functional changes in a discrete area of the cerebral cortex.
Neurophysiological studies have shown that slow changes in cortical scalp potential reflect overall activity of cortical neuronal networks. These scalp potentials reflect shifts in membrane potentials of the cortical neurons. Over the past 7 years tDCS has evolved as an important tool to non-invasively manipulate specific neural circuits of the human brain.
The purpose of this study is an investigation of tDCS applied to 20 therapy-resistance major depressive patients. Our hypothesis is that tDCS may exert an antidepressant effect and/or enhances the medication effect. tDCS will be examined in the framework of a placebo-controlled clinical pilot-study investigating effectiveness, safety and influence on EEG parameters. Patients will receive anodal DC stimulation or sham stimulation (extra designed placebo-stimulator) in a double-blind design over 10 days for each condition. Outcomes will be evaluated using several clinical, psychiatric and neuropsychological rating scales.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Frank Padberg, MD, PhD | 49-89-5160-5879 | padberg@med.uni-muenchen.de |
Contact: Daniel Keeser, MSc | 49-89-153-314 | daniel.keeser@med.uni-muenchen.de |
Germany | |
Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich | Recruiting |
Munich, Germany, 80336 | |
Contact: Frank Padberg, MD, PhD, PD 49-89-5160-5879 padberg@med.uni-muenchen.de | |
Contact: Daniel Keeser, MSc 49-89-153-314 daniel.keeser@med.uni-muenchen.de |
Principal Investigator: | Frank Padberg, MD, PhD | Dept. of Psychiatry, Ludwig-Maximilians-University Munich |
Responsible Party: | Dept. of Psychiatry, Ludwig-Maximilians-University Munich ( Frank Padberg, MD, PhD ) |
Study ID Numbers: | 01/2007 |
Study First Received: | April 24, 2008 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00667680 History of Changes |
Health Authority: | Germany: Ethics Commission |
tDCS, major depression |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |