Neuro-modulation of the Depressed Brain Using Working Memory Training and Transcranial Direct Current Stimulation (tDCS)
This study is currently recruiting participants.
Verified March 2012 by University of Sao Paulo
Sponsor:
University of Sao Paulo
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: March 24, 2012
Last verified: March 2012
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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.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434836
Contacts
| Contact: Andre R Brunoni, MD | +551130919241 | pesquisacientificahu@gmail.com |
Locations
| Brazil | |
| University of São Paulo, Hospital Universitário | Recruiting |
| Sao Paulo, SP, Brazil, 05508-000 | |
| Contact +551130919241 pesquisacientificahu@gmail.com | |
| Principal Investigator: Andre R Brunoni, MD | |
| Universidade Presbiteriana Mackenzie | Recruiting |
| Sao Paulo, SP, Brazil | |
| Contact: Lissa neurociencia@mackenzie.br | |
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: | March 24, 2012 |
| 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 May 22, 2013