Neuro-modulation of the Depressed Brain Using Working Memory Training and tDCS
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Hamilton Depression Rating Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
active tDCS and working memory training
Intervention: active tDCS and working memory training (Other)
sham tDCS and working memory training
Intervention: sham tDCS and working memory training (Other)
Outcomes
Primary Outcomes
Hamilton Depression Rating Scale
Time Frame: 4 weeks
The primary outcome measure is the score of HDRS-24 scale after 4 weeks of treatment.
Secondary Outcomes
- Salivary Cortisol(2 weeks)
- Working memory task in combination with pupil dilatation(2 weeks)
- Heart Rate Variability(2 weeks)
- Beck Depression Inventory(4 weeks)
- follow-up measure(after two weeks)
- Internal Shift Task(2 weeks)
Investigators
Andre Brunoni
Research Associate
University of Sao Paulo