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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03039387
Other study ID # 01EE1403D
Secondary ID
Status Recruiting
Phase N/A
First received October 28, 2016
Last updated January 30, 2017
Start date September 2016
Est. completion date April 2017

Study information

Verified date August 2016
Source University Hospital Tuebingen
Contact Christian Plewnia, MD
Phone +49 (0)7071-2986121
Email christian.plewnia@uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Deficient cognitive control (CC) and the use of dysfunctional emotion regulation strategies (ERS) are both central characteristics of major depression. Both are associated with reduced activity of the dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a safe, simple and effective non-invasive method to modulate the cortical excitability. The goal of this randomized, sham-controlled, double blind clinical trial is to examine the effect of transcranial direct current stimulation (tDCS) on the CC and ERS in depressed patients compared to healthy subjects. Overall, the study will include 44 participants (22 depressed Patients and 22 healthy subjects). Each participant will complete a CC task while receiving sham tDCS in one session and anodal tDCS in the other session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting phase by means of a questionnaire and psychophysiological measures (heart rate variability). The investigators hypothesize (a) an amelioration of CC by anodal tDCS and (b) a reduced use of the dysfunctional emotion regulation strategy 'rumination' after anodal tDCS. Overall this experiment will provide new and reliable data for the development of new treatment methods.


Description:

1. Working hypothesis: anodal transcranial direct current stimulation (tDCS) of the dorsolateral prefrontal cortex (dlPFC) can enhance healthy and impaired cognitive control (CC) and reduce the use of dysfunctional emotion regulation strategies.

2. Previous work of the investigators: The investigators previous work has provided decisive evidence for polarity-specific activity-dependent effects of tDCS to the left dlPFC on cognitive planning and control of emotional information processing in healthy subjects and patients with MD. Particularly, reduced prefrontal brain activity during a working memory task in patients with MD was found by using near infrared spectroscopy (NIRS). In addition, the investigators demonstrated that a single session, anodal, activity enhancing tDCS to the left dlPFC ameliorates deficient CC in patients with depression, whereas cathodal, activity reducing tDCS, induces a depression-like negativity bias in healthy subjects. Furthermore, the investigators showed that during anodal tDCS of the left dlPFC healthy subjects showed (a) better performance in a CC task (b) no increase in angry mood after the task compared to a control group and (c) that elevated angry mood was associated to a worse performance in the CC task.

3. Aims and workplan: to investigate the effects of anodal tDCS of the left dLPFC in healthy and depressed subjects the investigators will conduct a double-blind, randomized, sham-controlled, cross-over design. In two sessions each participant (22 depressed and 22 healthy subjects, N= 44) will complete a CC task while receiving anodal tDCS (1 mA) to the left dlPFC in one session and sham tDCS in the other session (counterbalanced). Afterwards the ERS 'rumination' will be measured during a resting phase by means of a questionnaire and psychophysiological measures.


Recruitment information / eligibility

Status Recruiting
Enrollment 44
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria for depressed patients

- diagnosed major depression (DSM-V)

- stable medication for four weeks

Inclusion Criteria for all participants

- right handedness

Exclusion Criteria:

- history of seizures

- metal device throughout the body

- pregnancy

- use of von antipsychotics / mood stabilizer

- diagnosed bipolar disorder

- current substance abuse (nicotine excluded)

- diagnosed psychotic diseases

- diagnosed anorexia nervosa

- diagnosed personality disorders: cluster A, antisocial personality disorder, borderline personality disorder

Exclusion Criteria for healthy participants:

- history of affective disorders or current affective disorder

Study Design


Intervention

Device:
anodal transcranial direct current stimulation

transcranial direct current stimulation (sham)
for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down.

Locations

Country Name City State
Germany University Hospital Tuebingen Tubingen Baden-Württemberg

Sponsors (3)

Lead Sponsor Collaborator
University Hospital Tuebingen German Federal Ministry of Education and Research, Universität Tübingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Interstimulusintervall and number of correct trials in the PASAT To measure the performance in the PASAT the number of correct trials as well as the mean Interstimulusintervall will be assessed. Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days.
Primary Change of positive and negative affect Change of positive and negative affect after, compared to before performing the PASAT and also change of the affect during the resting phase. The positive and negative affect is assessed (a) right before and after the PASAT in two sessions through study completion, on average 10 days. And (b) also after the resting phase in two sessions through study completion, on average 10 days.
Primary Heart rate variability The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect. in two sessions through study completion, on average 10 days
Primary Score in state rumination questionnaire The state rumination will be measured after the resting phase in two sessions through study completion, on average 10 days
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