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

This study has been completed.
Sponsor:
Collaborators:
Universidade Presbiteriana Mackenzie
University Ghent
Information provided by (Responsible Party):
Andre Brunoni, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01434836
First received: September 9, 2011
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Depression
Other: active tDCS and working memory training
Other: sham tDCS and working memory training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuro-modulation of the Depressed Brain Using Working Memory Training and tDCS

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.


Secondary Outcome Measures:
  • Beck Depression Inventory [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The outcome measure is the score of BDI scale after 4 weeks of treatment.

  • follow-up measure [ Time Frame: after two weeks ] [ Designated as safety issue: No ]
    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.

  • Internal Shift Task [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Working memory task in combination with pupil dilatation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.

  • Heart Rate Variability [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Salivary Cortisol [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active tDCS and working memory training Other: active tDCS and working memory training
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.
Placebo Comparator: sham tDCS and working memory training Other: sham tDCS and working memory training
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434836

Locations
Brazil
University of São Paulo, Hospital Universitário
Sao Paulo, SP, Brazil, 05508-000
Universidade Presbiteriana Mackenzie
Sao Paulo, SP, Brazil
Sponsors and Collaborators
University of Sao Paulo
Universidade Presbiteriana Mackenzie
University Ghent
Investigators
Principal Investigator: Andre R Brunoni, MD University of São Paulo
  More Information

No publications provided

Responsible Party: Andre Brunoni, Research Associate, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01434836     History of Changes
Other Study ID Numbers: tDCS_Training
Study First Received: September 9, 2011
Last Updated: May 30, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
Anti-depressant effects

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014