Skip to main content
OpenTrials
Completed

NCT Number: NCT01434836

Neuro-modulation of the Depressed Brain Using Working Memory Training and Transcranial Direct Current Stimulation (tDCS)

The goal of this project is to train currently major depressed patients on fundamental aspects of working memory while the investigators administer transcranial Direct Current Stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during these training sessions. This working memory training would be performed using adaptive Paced Auditory Serial Addition Tasks (PASAT). The effects after two weeks of working memory training combined with tDCS or sham placebo (10 sessions) will be measured on different variables, each measured at the start and at the end of the two weeks of training. The investigators expect the greatest anti depressant results and cognitive enhancements in the group of depressed patients that received tDCS combined with working memory training.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universidade Presbiteriana Mackenzie, São Paulo, Brazil

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Depressive Disorder, Major (SCID)
  • HDRS-24 > 21

Exclusion criteria

-Other axis I disorders, including Bipolar Disorder, Schizophrenia, Substance Abuse Disorders.

Any axis II disorders.

  • Any serious/life-threatening axis III disorders, such as Congestive Heart Failure, Pulmonary Obstructive Chronic Disease, Active Neoplasia.
  • Neurological diseases such as Stroke (and Post-Stroke Depression), Dementias and others.

Treatment and study plan

active tDCS and working memory training

Other

This group will receive 2.0 mA anodal DC stimulation over the left DLPFC and cathodal stimulation over the right DLPFC. During the stimulation, this group will be trained on working memory processes. Sessions will be scheduled daily for two consecutive weeks.

sham tDCS and working memory training

Other

This group will receive sham stimulation (e.g., identical stimulation set-up but no electric current is sent through the electrodes). Patients however receive the real working memory training, daily, for two weeks.

Primary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: 4 weeks

    The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: 4 weeks

    The outcome measure is the score of BDI scale after 4 weeks of treatment.

  2. follow-up measure

    Time frame: after two weeks

    Two weeks after each participant finished his/her treatment, the investigators will contact them to verify whether treatment induces long-lasting effects. This contact will be established via email and we will ask them to fill in the same self report questionnaires as they filled in during the study protocol.

  3. Internal Shift Task

    Time frame: 2 weeks

    The Internal Shift Task (IST), an emotional attention paradigm, will be administered to measure the ability to switch attention between emotional and non emotional items in working memory. After 10 sessions of tDCS in combination with the working memory training, the investigators expect a transfer effect on an increased switching ability between emotional stimuli.

  4. Working memory task in combination with pupil dilatation

    Time frame: 2 weeks

    This task will be administered to measure participants' ability to manipulate emotional information in working memory: either reverse or maintain in the order of three emotion or three neutral words. The investigators hypothesize that the pupil size will be decreased when sorting negative words in working memory in depressed patients that received active tDCS over the left DLPFC in combination with attentional training.

  5. Heart Rate Variability

    Time frame: 2 weeks

    This measure will be utilized to evaluate autonomic activity by recording electrocardiogram or pulse wave. High HRV has been associated with greater behavioral adaptability and plays a major role in the adaptive recovery from stress. After the treatment, the investigators expect MDD patients that received tDCS with working memory training to demonstrate increased HRV while viewing negative high arousing IAPS pictures.

  6. Salivary Cortisol

    Time frame: 2 weeks

    This measure will be utilized to evaluate endocrinological response of the hypothalamic-pituitary-adrenal(HPA)axis, such as cortisol secretion. After the treatment, the investigators expect MDD patients that received tDCS with working memory training to demonstrate decreased cortisol secretion while viewing negative high arousing IAPS pictures.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Universidade Presbiteriana Mackenzie
  • University Ghent

Registry information

Official study title

Neuro-modulation of the Depressed Brain Using Working Memory Training and tDCS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2011
Registry last updated
Jun 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.