Abstract
Background: Stroke is one of the leading causes of disability worldwide. Functional impairment, resulting in poor performance in activities of daily living (ADL) among stroke survivors is common. Current rehabilitation approaches have limited effectiveness in improving ADL performance, function, muscle strength, and cognitive abilities (including spatial neglect) after stroke, with improving cognition being the number one research priority in this field. A possible adjunct to stroke rehabilitation might be non-invasive brain stimulation by transcranial direct current stimulation (tDCS) to modulate cortical excitability, and hence to improve these outcomes in people after stroke. Objectives: To assess the effects of tDCS on ADL, arm and leg function, muscle strength and cognitive abilities (including spatial neglect), dropouts and adverse events in people after stroke. Search methods: We searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase and seven other databases in January 2019. In an effort to identify further published, unpublished, and ongoing trials, we also searched trials registers and reference lists, handsearched conference proceedings, and contacted authors and equipment manufacturers. Selection criteria: This is the update of an existing review. In the previous version of this review, we focused on the effects of tDCS on ADL and function. In this update, we broadened our inclusion criteria to compare any kind of active tDCS for improving ADL, function, muscle strength and cognitive abilities (including spatial neglect) versus any kind of placebo or control intervention. Data collection and analysis: Two review authors independently assessed trial quality and risk of bias, extracted data, and applied GRADE criteria. If necessary, we contacted study authors to ask for additional information. We collected information on dropouts and adverse events from the trial reports. Main results: We included 67 studies involving a total of 1729 patients after stroke. We also identified 116 ongoing studies. The risk of bias did not differ substantially for different comparisons and outcomes. The majority of participants had ischaemic stroke, with mean age between 43 and 75 years, in the acute, postacute, and chronic phase after stroke, and level of impairment ranged from severe to less severe. Included studies differed in terms of type, location and duration of stimulation, amount of current delivered, electrode size and positioning, as well as type and location of stroke. We found 23 studies with 781 participants examining the effects of tDCS versus sham tDCS (or any other passive intervention) on our primary outcome measure, ADL after stroke. Nineteen studies with 686 participants reported absolute values and showed evidence of effect regarding ADL performance at the end of the intervention period (standardised mean difference (SMD) 0.28, 95% confidence interval (CI) 0.13 to 0.44; random-effects model; moderate-quality evidence). Four studies with 95 participants reported change scores, and showed an effect (SMD 0.48, 95% CI 0.02 to 0.95; moderate-quality evidence). Six studies with 269 participants assessed the effects of tDCS on ADL at the end of follow-up and provided absolute values, and found improved ADL (SMD 0.31, 95% CI 0.01 to 0.62; moderate-quality evidence). One study with 16 participants provided change scores and found no effect (SMD -0.64, 95% CI -1.66 to 0.37; low-quality evidence). However, the results did not persist in a sensitivity analysis that included only trials with proper allocation concealment. Thirty-four trials with a total of 985 participants measured upper extremity function at the end of the intervention period. Twenty-four studies with 792 participants that presented absolute values found no effect in favour of tDCS (SMD 0.17, 95% CI -0.05 to 0.38; moderate-quality evidence). Ten studies with 193 participants that presented change values also found no effect (SMD 0.33, 95% CI -0.12 to 0.79; low-quality evidence). Regarding the effects of tDCS on upper extremity function at the end of follow-up, we identified five studies with a total of 211 participants (absolute values) without an effect (SMD -0.00, 95% CI -0.39 to 0.39; moderate-quality evidence). Three studies with 72 participants presenting change scores found an effect (SMD 1.07; 95% CI 0.04 to 2.11; low-quality evidence). Twelve studies with 258 participants reported outcome data for lower extremity function and 18 studies with 553 participants reported outcome data on muscle strength at the end of the intervention period, but there was no effect (high-quality evidence). Three studies with 156 participants reported outcome data on muscle strength at follow-up, but there was no evidence of an effect (moderate-quality evidence). Two studies with 56 participants found no evidence of effect of tDCS on cognitive abilities (low-quality evidence), but one study with 30 participants found evidence of effect of tDCS for improving spatial neglect (very low-quality evidence). In 47 studies with 1330 participants, the proportions of dropouts and adverse events were comparable between groups (risk ratio (RR) 1.25, 95% CI 0.74 to 2.13; random-effects model; moderate-quality evidence). Authors' conclusions: There is evidence of very low to moderate quality on the effectiveness of tDCS versus control (sham intervention or any other intervention) for improving ADL outcomes after stroke. However, the results did not persist in a sensitivity analyses including only trials with proper allocation concealment. Evidence of low to high quality suggests that there is no effect of tDCS on arm function and leg function, muscle strength, and cognitive abilities in people after stroke. Evidence of very low quality suggests that there is an effect on hemispatial neglect. There was moderate-quality evidence that adverse events and numbers of people discontinuing the treatment are not increased. Future studies should particularly engage with patients who may benefit the most from tDCS after stroke, but also should investigate the effects in routine application. Therefore, further large-scale randomised controlled trials with a parallel-group design and sample size estimation for tDCS are needed.
| Original language | English |
|---|---|
| Article number | CD009645 |
| Journal | Cochrane Database of Systematic Reviews |
| Volume | 2020 |
| Issue number | 11 |
| ISSN | 1465-1858 |
| DOIs | |
| Publication status | Published - 11.11.2020 |
Funding
Supported by the Korea Research Foundation Grant funded by the Korean Government (KRF-2008-1093-000) and by a KOSEF grant funded by the Korean government (M10644000022-06N4400-02210) This study received financial support from Conselho Nacional de Pesquisa (CNPq) (grant universal 461254/2014-0) and in part by the Coordenacao de Aperfeicoamento de Pessoal de Nível Superior – Brasil (CAPES, finance code 001). 1. FMA 2. WMFT 3. MAS 4. surface EMG 5. TMS to measure the corticomotor excitability of the lesioned primary motor cortex (M1) This work was supported by the National Natural Science Foundation of China (No. 51475292, No. 61761166006), and the Shanghai Municipal Commission of Health and Family Planning (No. 2017ZZ01006) Carlotta Martinuzzi and Claudia Pavarelli were supported by Emilia Romagna region (Grant 1786/2012) This work was funded in part by the Cardinal Hill Stroke and Spinal Cord Injury Endowment #0705129700 and the American Heart Association Grant #11CRP7220009 This study was financially supported by the BEVICA foundation This research was supported by the Brazilian National Counsel of Technological and Scientific Development (CNPQ), and Coordination for the improvement of higher Education Personnel (CAPES) This work was supported by the American Heart Association (0735535T) (FF), University of Milano-Bic-occa (NB, GV), IRCCS Istituto Auxologico Italiano (NB, GV, LT), Regione Lombardia-Ricerca Finalizzata 2009 (LT, CC) This study was supported by the National Research Foundation of Korea (Grant No. 2011-0016960), by the Samsung Medical CenterClinical Research Development Program (#CRDP CRS-110-05-1), and by a KOSEF grant (M10644000022-06N4400-02210) funded by the Korean Government This research was supported by grant (number 484488/2013-9) from Conselho Nacional de Desenvolvi-mento Científico e Tecnológico (CNPq). Sérgio Rocha Rocha was supported by Fudancao de Amparo a Ciência e Tecnologia do Estado de Pernambuco (FACEPE). Evelyn Silva and Águida Foerster was supported by CNPq Supported by a grant from Helping Water Foundation (to NJP) This research work was supported by grants from the National Institute of Health (RO1 NS045049, RO1DC008796), CIMIT, Mary Crown and William Ellis Family Fund This work was supported by grants from Fondation de l’Avenir (ET9-531), by INSERM (C09-27), the Clinical Research Center of Toulouse (CIC), and Toulouse University Hospital This work was supported by the National Institutes of Health (1K01HD069504) and American Heart Association (13BGIA17120055) to EBP as well as by the Clinical & Translational Science Collaborative (RPC2014-1067) to DAC. Conflicts of Interest: AM has the following conflicts of interest to disclose: ATI, Enspire and Cardionomics (distribution rights from intellectual property), Spinal Modulation and Functional Neurostimulation (consultant). This study was supported by the National Research Foundation grant funded by the Korean government (MSIP) (NRF-2014R1A2A1A01005128) This research was supported by Basic Science Research Program through the National Research Foundation of Korea (NRF) and funded by the Ministry of Education, Science and Technology (grant no. 2010-0004373) This work was supported by a research grant from the Faculty of Physical Therapy, Mahidol University (2016/018.2901) This work was supported by a grant within the Harvard Medical School Scholars in Clinical Science Program (NIH K30 HL04095-03) to F.F. and by K24 RR018875, RO1-NS 47754, RO1-NS 20068 to A.P.-L. This work was supported by the Science and Engineering Research Council of A*STAR (Agency for Science, Technology and Research), and the National Medical Research Council, Singapore QM Wang was supported by NIHK08 (HD074668) Supported by the NIH/NINDS (NS045049) The work of TVI was supported by the Ministry of Education and Science of the Republic of Serbia (Project No. 41014) and the Ministry of Defence of the Republic of Serbia (Project MFV-MA/07/16-18). The work of SDM was supported by a grant from the Ministry of Education and Science of the Republic of Serbia (Project No. 175012) This work was supported by a grant within the Harvard Medical School Scholars in Clinical Science Program (NIHK30 HL04095-03) to F.F. and by K24 RR018875, RO1-NS 47754, RO1-NS 20068 to A.P.-L. This work was supported by the Korea Science and Engineering Foundation (KOSEF) grant funded by the Korean Government (MOST) (No. M10644000022-06N4400-02210) This study was partially supported by an American Heart Association (AHA) grant (grant number 0735535T) This paper was supported by research funds provided from Howon University, Republic of Korea This publication was supported by the National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1RR033173 This research was supported by a grant from Seoul National University College of Medicine (Grant No. 800-20060236) to NJ Paik, and by a grant from the Korean Geriatric Society to EK Kang
Research Areas and Centers
- Health Sciences
DFG Research Classification Scheme
- 2.23-07 Clinical Neurology, Neurosurgery and Neuroradiology
- 2.23-08 Human Cognitive and Systems Neuroscience