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

Phase 2

Completed

• Conditions: Depression
• Interventions: Other: active tDCS and working memory training; Other: sham tDCS and working memory training

• Registration Number: NCT01434836
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-14
• Study First Posted: 2011-09-15
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-30
• Last Update Posted: 2013-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active tDCS and working memory training	active tDCS and working memory training	-
sham tDCS and working memory training	sham tDCS and working memory training	-

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	4 weeks	The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Salivary Cortisol	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.
Working memory task in combination with pupil dilatation	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.
Heart Rate Variability	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.
follow-up measure	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.
Beck Depression Inventory	4 weeks	The outcome measure is the score of BDI scale after 4 weeks of treatment.
Internal Shift Task	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.

Trial Locations

Locations (2)

Universidade Presbiteriana Mackenzie; 🇧🇷 Sao Paulo, SP, Brazil

University of São Paulo, Hospital Universitário; 🇧🇷 Sao Paulo, SP, Brazil