Ignite Creation Date:
2024-05-06 @ 12:13 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01525524
Status:
COMPLETED
Last Update Posted:
2014-09-09
First Post:
2012-01-24
Brief Title:
Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Treatment of Major Depressive Disorder Post Stroke With Transcranial Direct Current Stimulation TDCS Randomized Double-Blind Clinical Trial
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 MADRSMontgomery-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None