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Disorder-tailored Transcranial Direct Current Stimulation (tDCS) of the Prefrontal Cortex

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02715128
Recruitment Status : Not yet recruiting
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Information provided by (Responsible Party):
Daniel Keeser, Ludwig-Maximilians - University of Munich

Brief Summary:

Major depressive disorder (MDD) is a common, recurrent, and frequent chronic disorder. Among others, deficient cognitive control over emotional distraction is a central characteristic of MDD (Ochsner & Gross 2005; Disner et al. 2011; Beck 2008). Hypoactivation of the dorsolateral prefrontal cortex (DLPFC) has been linked with this deficit (Dolcos & McCarthy 2006). Moreover, aberrant functional connectivity patterns have been found in MDD patients (Kaiser et al. 2015). Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has been largely investigated in experimental neurosciences and tDCS of the prefrontal cortex (PFC) has been proposed as novel treatment in MDD. So far, prefrontal tDCS has been shown to enhance cognitive control over emotional distraction in MDD patients (Wokenstein & Plewnia 2013). Also, tDCS-induced connectivity changes found in fMRI studies comparing resting-state networks configurations before and after prefrontal tDCS may reflect a state of enhanced alertness (Keeser, Meindl, et al., 2011; Park et al., 2013).

The aim of this study is to investigate the neurophysiological correlates of tDCS effects in MDD patients. For this purpose, functional magnetic resonance imaging (fMRI) data is collected during the execution of a cognitive control task as well as during a resting-state condition following real or sham tDCS. It is hypothesized that prefrontal tDCS as compared to sham a) reduces distractibility by compensating for deficient DLPFC activity and b) enhances functional connectivity in networks associated with externally directed attention or cognitive engagement.

In this placebo-controlled study patients with a diagnosis of MDD receive a single treatment with prefrontal tDCS (anode over electrode position F3, cathode over F4, 20 min, 2mA intensity) or sham tDCS (frequency and duration correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation). Before, during, and after the treatment resting-state measurements in the fMRI scanner are conducted. Subsequently, participants perform the cognitive control task (in dependence of Plewnia, C., Schroeder, P. A., & Wolkenstein, L. (2015)) in the scanner. The patients are assigned to either the real or sham tDCS condition according to a randomised, double-blind parallel design.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial direct current stimulation (tDCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Disorder-tailored Transcranial Direct Current Stimulation (tDCS) of the Prefrontal Cortex: fMRI Study in Major Depression
Study Start Date : March 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: real tDCS
anode over electrode position F3, cathode over F4, 20 min, 2mA intensity
Device: Transcranial direct current stimulation (tDCS)
non-invasive electric brain stimulation method

Sham Comparator: sham tDCS
frequency and duration correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation
Device: Transcranial direct current stimulation (tDCS)
non-invasive electric brain stimulation method

Primary Outcome Measures :
  1. FMRI modulations [ Time Frame: 2 hours ]
    differences in the cognitive control task (performance and activations) between the sham and real group as well as changes in resting-state connectivity between and within (following stimulation compared to baseline) groups

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Men and women 18-65 years of age.
  • Primary DSM-5 diagnosis of Major Depression as assessed by the Structured Clinical Interview for DSM-5 Axis I Disorders, Research Version (SCID-5-RV) with a single or recurrent episode with the additional requirements of a current episode with a duration of ≥4 weeks.
  • Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-5 definition of major depressive episode).
  • Total HDRS-21 ≥15 at the screening visit.
  • No antidepressant medication and stable medication ≥4 weeks.
  • Capable and willing to provide informed consent.
  • Negative pregnancy test and willingness to use contraceptive measures during study treatment for women with childbearing potential (i.e. < 2 years post-menopausal)

Exclusion Criteria:

  • Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption).
  • Acute risk for suicide (MADRS, item 10 score of >4 or as assessed by the C-SSRS, agree to item 4 and/or agree to item 5).
  • High degree of therapy resistance defined as >4 sufficient treatment attempts in the current episode (each attempt with an ATHF score of >3).
  • Treatment with electroconvulsive therapy in the present episode.
  • Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants).
  • Any other relevant psychiatric axis-I- and/or axis-II-disorder.
  • Any relevant instable medical condition.
  • History of treatment with tDCS for any disorder.
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02715128

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Contact: Frank Padberg, Prof. Dr. +40 (0)89 440053358

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Department of Psychiatry and Psychotherapy, Ludwig-Maximilian University Munich
Munich, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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Principal Investigator: Frank Padberg, Prof. Dr. Ludwig-Maximilians-Universität München

Additional Information:

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Responsible Party: Daniel Keeser, Dr. rer. biol. hum., Ludwig-Maximilians - University of Munich Identifier: NCT02715128     History of Changes
Other Study ID Numbers: 493-14
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders