Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation

Study Overview
=================
Brief 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.

Official Title
-----------------
Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation (TDCS): Randomized, Double-Blind, Clinical Trial

Conditions
-----------------
Major Depressive Disorder 1

Intervention / Treatment
-----------------
* Device: Transcranial Direct Current Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Depressive Disorder after stroke First episode of Stroke Hamilton > 17 Exclusion Criteria: Others severe neurologic conditions Others Axis I besides anxiety Important suicidal ideation Use of antidepressants

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham Stimulation<br>In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex with the Transcranial Direct Current Stimulation. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp. The device will deliver a charge of 2mA for 1 minute, after that the device will be automatically turned off for 29 minutes. | Device: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: Transcranial Stimulation;|
| Active Comparator: Active Stimulation<br>In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex with the transcranial Direct Current Stimulation device. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp. The device will deliver a charge of 2mA for 30 minutes. | Device: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: Transcranial Stimulation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response | Hamilton of active will be lower than sham group | Week 4 after tenth day of tDCS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response | Response is defined as less than 50% of baseline Hamilton | Week 4 after tenth day of tDCS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tDCS, Major Depression, Stroke