- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01434836
Neuro-modulation of the Depressed Brain Using Working Memory Training and Transcranial Direct Current Stimulation (tDCS)
May 30, 2013 updated by: Andre Brunoni, University of Sao Paulo
Neuro-modulation of the Depressed Brain Using Working Memory Training and tDCS
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Sao Paulo, SP, Brazil, 05508-000
- University of São Paulo, Hospital Universitário
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Sao Paulo, SP, Brazil
- Universidade Presbiteriana Mackenzie
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hamilton Depression Rating Scale
Time Frame: 4 weeks
|
The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory
Time Frame: 4 weeks
|
The outcome measure is the score of BDI scale after 4 weeks of treatment.
|
4 weeks
|
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.
|
after two weeks
|
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.
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2 weeks
|
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.
|
2 weeks
|
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.
|
2 weeks
|
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.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andre R Brunoni, MD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
September 9, 2011
First Submitted That Met QC Criteria
September 14, 2011
First Posted (Estimate)
September 15, 2011
Study Record Updates
Last Update Posted (Estimate)
June 3, 2013
Last Update Submitted That Met QC Criteria
May 30, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- tDCS_Training
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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