Neuro-modulation of the Depressed Brain Using Working Memory Training and Transcranial Direct Current Stimulation (tDCS)
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|ClinicalTrials.gov Identifier: NCT01434836|
Recruitment Status : Completed
First Posted : September 15, 2011
Last Update Posted : June 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression||Other: active tDCS and working memory training Other: sham tDCS and working memory training||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Neuro-modulation of the Depressed Brain Using Working Memory Training and tDCS|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
|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.
- Hamilton Depression Rating Scale [ Time Frame: 4 weeks ]The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.
- Beck Depression Inventory [ Time Frame: 4 weeks ]The outcome measure is the score of BDI scale after 4 weeks of treatment.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434836
|University of São Paulo, Hospital Universitário|
|Sao Paulo, SP, Brazil, 05508-000|
|Universidade Presbiteriana Mackenzie|
|Sao Paulo, SP, Brazil|
|Principal Investigator:||Andre R Brunoni, MD||University of São Paulo|