Background Post-stroke depression is a disabling condition occurring in about one-third of patients with stroke. Pharmacological treatments have limited efficacy and important side effects. Recently, transcranial direct current stimulation (tDCS) has shown efficacy in treating depression. This study aimed to assess the efficacy and safety of tDCS for post-stroke depression.
Methods 48 antidepressant-free patients with post-stroke depression were randomised into two groups (active and sham tDCS). 12 30 min sessions of 2 mA anodal left/cathodal right dorsolateral prefrontal tDCS were administered over 6 weeks (once daily on weekdays for 2 weeks, then 1 session every other week). The primary outcome was the change in the Hamilton Depression Rating Scale (17-items) at 6 weeks. We employed a repeated-measures analysis of variance; the depression score was the dependent variable, and time and group were independent variables. In this intention-to-treat analysis, missing data were addressed according to the last observation carried forward and the mixed-model repeated-measures analysis methods.
Results 5 patients dropped out (two in the active group). Active tDCS was significantly superior to sham at end point (mean difference, 4.7 points; SD=9.21; p<0.001). Response and remission rates were significantly higher in the active (37.5% and 20.8%, respectively) versus the sham (4.1% and 0%, respectively) group, with a number-needed-to-treat of 3 and 5, respectively.
Conclusions This was the first controlled study to demonstrate that tDCS was safe and effective for post-stroke depression. Therefore, tDCS might be a favourable option for treating these patients.
Trial registration number NCT01525524; Results.
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Contributors LCLV and ARB had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. LCLV, ACG and ARB designed the study. LCLV, JFO and ARB collected the study data. LCLV and ARB analysed the data and wrote the first draft of the paper. All authors discussed the results and commented on the manuscript at all stages.
Funding This work was supported by a research grant from São Paulo Research State Foundation (Fundação de Amparo à Pesquisa do Estado de São Paulo, FAPESP Grant Number 2011/22872-4; 2012/20911-5), awarded to ACG. FAPESP is an independent public foundation and had no role in any aspect of the study, including: design and conduct of the study; collection, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript. ARB was supported by the following grants: 2013 NARSAD Young Investigator from the Brain & Behavior Research Foundation (grant number 20493), 2013 FAPESP Young Researcher from the São Paulo State Foundation (grant number 20911-5), and National Council for Scientific and Technological Development (CNPq, grant number 470904). ARB also received equipment from Soterix Medical (not used in this study). LCLV was awarded a research grant from Stanley Medical Foundation.
Competing interests None declared.
Ethics approval Brazilian National Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Owing to the ethically sensitive nature of the research, supporting data cannot be made openly available. Anonymised data can be provided on request.