Effects of tDCS on Cognitive Control and Emotion Regulation in Depressed Patients

NCT ID: NCT03039387

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-04-30

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

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.

Conditions

Anodal Stimulation tDCS; Major Depression; Cognitive Control; Emotion Regulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

anodal tDCS

transcranial direct current stimulation of the left dlPFC with 1mA

Group Type: ACTIVE_COMPARATOR

anodal transcranial direct current stimulation

Intervention Type: DEVICE

Sham stimulation

Double blind sham stimulation (stimulation will be ramped down after 30 sec.)

Group Type: PLACEBO_COMPARATOR

transcranial direct current stimulation (sham)

Intervention Type: DEVICE

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

Interventions

anodal transcranial direct current stimulation

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

anodal tDCS; sham tDCS

Eligibility Criteria

Inclusion Criteria

• diagnosed major depression (DSM-V)
• stable medication for four weeks

• 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

• history of affective disorders or current affective disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

Universität Tübingen

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christian Plewnia, MD

Role: CONTACT

christian.plewnia@uni-tuebingen.de

+49 (0)7071-2986121

Facility Contacts

Christian Plewnia, Prof., MD

Role: primary

christian.plewnia@uni-tuebingen.de

0049 7071 29 86121

Anja Sommer, M.Sc.

Role: backup

anja.sommer@med.uni-tuebingen.de

0049 7071 29 86127

Other Identifiers

01EE1403D

Identifier Type: -

Identifier Source: org_study_id