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

This study is currently recruiting participants.
Verified October 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Leandro Valiengo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01525524
First received: January 24, 2012
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder 1
 Device: Transcranial Direct Current Stimulation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation (TDCS): Randomized, Double-Blind, Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Treatment response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Response is defined as less than 50% of baseline Hamilton


Secondary Outcome Measures:
  • Treatment response [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Response is defined as less than 50% of baseline MADRS


Estimated Enrollment: 48
Study Start Date: January 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Transcranial Stimulation

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525524

Contacts
Contact: Leandro Valiengo pesquisaavchu@gmail.com

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil
Principal Investigator: Leandro Valiengo, MD            
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Leandro Valiengo, MD HU-USP
  More Information

No publications provided

Responsible Party: Leandro Valiengo, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01525524     History of Changes
Other Study ID Numbers: 1180/12
Study First Received: January 24, 2012
Last Updated: October 8, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
tDCS
Major Depression
Stroke

Additional relevant MeSH terms:
Depressive Disorder
Depression
Stroke
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013