Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation
Condition: Major Depressive Disorder 1
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Stroke is one of the main public health problems in America Latina. It can be associated with
      several neuropsychiatric complications, which include a broad spectrum of emotional distress
      and cognitive, results in important clinical implications for the prognosis of these
      patients. Depression is a common complication, affecting around 5-72% of patients and is
      associated with various cognitive deficits and also with increased mortality - up to 50% more
      deaths compared to non-depressed patients. Treatment of depression after stroke is important
      not only to improve depressive symptoms but can also be beneficial for cognitive deficits,
      activities of daily living. and leads to increased survival for these patients. There are
      different treatments for depression after stroke, all showing inconclusive results, even
      though antidepressants have been effective in some groups of patients, tolerability and
      treatment adherence were not very good-so it is necessary that new therapeutic modalities are
      presented with good tolerability. In this sense, transcranial direct current stimulation
      (tDCS) is an interesting technique that can provide interesting results, which proved to be
      effective for depression in some studies. This study proposes to investigate the effect of
      tDCS for the treatment of major depressive disorder after stroke. The proposed design is a
      clinical trial, randomized, double-blind, placebo-controlled study in a subsample of
      participants in the prospective cohort of stroke: Study of Morbidity and Mortality of stroke.
      They will be allocated to one of the groups: sham or active tDCS group. Participants will
      receive ten consecutive days of active or sham stimulation and return at the end of two weeks
      to evaluate the improvement in depression, cognition and functionality. As objectives, the
      investigators expect to see a clinical improvement of depression through scales like
      Hamilton, Beck and MADRS(Montgomery-Asberg Depression Rating Scale), and expect improvement
      on cognitive tests as MoCA (Montreal Cognitive Assessment), MMSE (mini mental scale exam),
      FAB (frontal assessment battery) and trail test. Another goal is to see improvement in
      markers related to depression as BDNF, cortisol, interleukins and heart rate variability.
      With all this, the investigators hope to offer a new treatment, and effective with few side
      effects to treat depression after stroke.
    

Detailed description: 
      The Study of Morbidity and Mortality of stroke (EMMA) is a cohort study of patients with
      stroke.
    

Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): In active stimulation(active Transcranial Direct Current Stimulation), the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes.
Other intervention name(s): Transcranial Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; Major Depression; Stroke