Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients
Primary Purpose
Anodal Stimulation tDCS, Major Depression, Cognitive Control
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
anodal transcranial direct current stimulation
transcranial direct current stimulation (sham)
Sponsored by
About this trial
This is an interventional basic science trial for Anodal Stimulation tDCS
Eligibility Criteria
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
Sites / Locations
- University Hospital TuebingenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
anodal tDCS
Sham stimulation
Arm Description
transcranial direct current stimulation of the left dlPFC with 1mA
Double blind sham stimulation (stimulation will be ramped down after 30 sec.)
Outcomes
Primary Outcome Measures
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.
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.
Heart rate variability
The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect.
Score in state rumination questionnaire
The state rumination will be measured after the resting phase
Secondary Outcome Measures
Full Information
NCT ID
NCT03039387
First Posted
October 28, 2016
Last Updated
January 30, 2017
Sponsor
University Hospital Tuebingen
Collaborators
German Federal Ministry of Education and Research, Universität Tübingen
1. Study Identification
Unique Protocol Identification Number
NCT03039387
Brief Title
Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients
Official Title
The Effect of Transcranial Direct Current Stimulation (tDCS) on Cognitive Control and Emotion Regulation in Depressed Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
Collaborators
German Federal Ministry of Education and Research, Universität Tübingen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anodal Stimulation tDCS, Major Depression, Cognitive Control, Emotion Regulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anodal tDCS
Arm Type
Active Comparator
Arm Description
transcranial direct current stimulation of the left dlPFC with 1mA
Arm Title
Sham stimulation
Arm Type
Placebo Comparator
Arm Description
Double blind sham stimulation (stimulation will be ramped down after 30 sec.)
Intervention Type
Device
Intervention Name(s)
anodal transcranial direct current stimulation
Other Intervention Name(s)
anodal tDCS
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation (sham)
Other Intervention Name(s)
sham tDCS
Intervention Description
for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down.
Primary Outcome Measure Information:
Title
Interstimulusintervall and number of correct trials in the PASAT
Description
To measure the performance in the PASAT the number of correct trials as well as the mean Interstimulusintervall will be assessed.
Time Frame
Assessment during stimulation/ sham stimulation in two sessions through study completion, on average 10 days.
Title
Change of positive and negative affect
Description
Change of positive and negative affect after, compared to before performing the PASAT and also change of the affect during the resting phase.
Time Frame
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.
Title
Heart rate variability
Description
The Heart Rate Variability will be measured during the resting phase right after the measurement of the affect.
Time Frame
in two sessions through study completion, on average 10 days
Title
Score in state rumination questionnaire
Description
The state rumination will be measured after the resting phase
Time Frame
in two sessions through study completion, on average 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian Plewnia, MD
Phone
+49 (0)7071-2986121
Email
christian.plewnia@uni-tuebingen.de
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tubingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Plewnia, Prof., MD
Phone
0049 7071 29 86121
Email
christian.plewnia@uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Anja Sommer, M.Sc.
Phone
0049 7071 29 86127
Email
anja.sommer@med.uni-tuebingen.de
First Name & Middle Initial & Last Name & Degree
Christian Plewnia, Prof., MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients
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