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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434836
• Other study ID #: tDCS_Training
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2011
• Last updated: May 30, 2013
• Start date: September 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Presbiteriana Mackenzie	Sao Paulo	SP
Brazil	University of São Paulo, Hospital Universitário	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Universidade Presbiteriana Mackenzie, University Ghent

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale	The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.	4 weeks	No
Secondary	Beck Depression Inventory	The outcome measure is the score of BDI scale after 4 weeks of treatment.	4 weeks	No
Secondary	follow-up measure	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.	after two weeks	No
Secondary	Internal Shift Task	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.	2 weeks	No
Secondary	Working memory task in combination with pupil dilatation	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.	2 weeks	No
Secondary	Heart Rate Variability	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.	2 weeks	Yes
Secondary	Salivary Cortisol	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.	2 weeks	Yes