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

September 7, 2014 updated by: Leandro Valiengo, University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

48

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

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • University of Sao Paulo

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

30 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham Stimulation
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
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 Names:
  • Transcranial Stimulation
ACTIVE_COMPARATOR: Active Stimulation
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
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 Names:
  • Transcranial Stimulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Leandro Valiengo, MD, HU-USP

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.

General Publications

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

January 1, 2012

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

January 24, 2012

First Submitted That Met QC Criteria

February 2, 2012

First Posted (ESTIMATE)

February 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 7, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1180/12

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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