PMID- 27261431
OWN - NLM
STAT- MEDLINE
DCOM- 20171006
LR  - 20181202
IS  - 1876-4754 (Electronic)
IS  - 1876-4754 (Linking)
VI  - 9
IP  - 5
DP  - 2016 Sep-Oct
TI  - A Systematic Review on the Acceptability and Tolerability of Transcranial Direct 
      Current Stimulation Treatment in Neuropsychiatry Trials.
PG  - 671-681
LID - S1935-861X(16)30100-0 [pii]
LID - 10.1016/j.brs.2016.05.004 [doi]
AB  - BACKGROUND: Transcranial direct current stimulation (tDCS) is a non-invasive 
      brain stimulation investigated as a treatment for several neuropsychiatric 
      disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be 
      low and transient, systematic review analyses on safety and tolerability of tDCS 
      derive mostly from single-session studies. OBJECTIVE: To investigate the 
      tolerability (rate of AEs) and acceptability (rate of dropouts) of tDCS. METHODS: 
      Systematic review and meta-analysis of tDCS randomized, sham-controlled trials in 
      healthy or neuropsychiatric adult samples from the first date available to March 
      9, 2016. We only included parallel studies performing at least 5 tDCS sessions. 
      An adapted version of CONSORT guidelines for reporting harms outcomes was used to 
      evaluate AE reporting. RESULTS: Sixty-four studies (2262 participants) were 
      included. They had a low risk of publication bias and methodological bias for the 
      items assessed. Dropout rates in active and sham tDCS groups were, respectively, 
      6% and 7.2% (OR = 0.82 [0.59-1.14]). However, almost half of studies reported no 
      dropouts and only 23.4% reported its reasons; when reported, the most frequent 
      reasons were AEs and protocol violation. A tolerability meta-analysis was not 
      performed, as most studies did not report AEs. The quality of AEs reporting was 
      also limited, particularly in smaller studies and stroke studies. CONCLUSIONS: 
      Although overall dropout rate was low and similar in active and sham groups, 
      studies did not adequately describe AEs. An updated questionnaire and guidelines 
      for assessment of AEs in tDCS trials are proposed in order to standardize the 
      reporting of AE in the field.
CI  - Copyright (c) 2016 Elsevier Inc. All rights reserved.
FAU - Aparicio, Luana V M
AU  - Aparicio LVM
AD  - Center for Clinical and Epidemiological Research & Interdisciplinary Center for 
      Applied Neuromodulation (CINA), University Hospital, University of Sao Paulo, Sao 
      Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Department and 
      Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, 
      Brazil.
FAU - Guarienti, Fabiana
AU  - Guarienti F
AD  - Center for Clinical and Epidemiological Research & Interdisciplinary Center for 
      Applied Neuromodulation (CINA), University Hospital, University of Sao Paulo, Sao 
      Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Department and 
      Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, 
      Brazil.
FAU - Razza, Lais Boralli
AU  - Razza LB
AD  - Center for Clinical and Epidemiological Research & Interdisciplinary Center for 
      Applied Neuromodulation (CINA), University Hospital, University of Sao Paulo, Sao 
      Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Department and 
      Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, 
      Brazil.
FAU - Carvalho, Andre F
AU  - Carvalho AF
AD  - Department of Psychiatry and Translational Psychiatry Research Group, Faculty of 
      Medicine, Federal University of Ceara, Fortaleza, CE, Brazil.
FAU - Fregni, Felipe
AU  - Fregni F
AD  - Laboratory of Neuromodulation, Center for Clinical Research Learning, Department 
      of Physical Medicine and Rehabilitation, Harvard University, USA.
FAU - Brunoni, Andre Russowsky
AU  - Brunoni AR
AD  - Center for Clinical and Epidemiological Research & Interdisciplinary Center for 
      Applied Neuromodulation (CINA), University Hospital, University of Sao Paulo, Sao 
      Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Department and 
      Institute of Psychiatry, Faculty of Medicine, University of Sao Paulo, Sao Paulo, 
      Brazil; Laboratory of Neuroscience (LIM27), Department and Institute of 
      Psychiatry, University of Sao Paulo, Sao Paulo, Brazil. Electronic address: 
      brunoni@usp.br.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20160516
PL  - United States
TA  - Brain Stimul
JT  - Brain stimulation
JID - 101465726
SB  - IM
MH  - Clinical Trials as Topic
MH  - Humans
MH  - Pain Management/methods
MH  - Stroke Rehabilitation/*adverse effects/methods
MH  - Surveys and Questionnaires
MH  - Transcranial Direct Current Stimulation/*adverse effects/methods
OTO - NOTNLM
OT  - Acceptability
OT  - Adverse effects
OT  - Meta-analysis
OT  - Tolerability
OT  - Transcranial direct current stimulation
EDAT- 2016/06/05 06:00
MHDA- 2017/10/07 06:00
CRDT- 2016/06/05 06:00
PHST- 2016/01/19 00:00 [received]
PHST- 2016/05/05 00:00 [revised]
PHST- 2016/05/13 00:00 [accepted]
PHST- 2016/06/05 06:00 [entrez]
PHST- 2016/06/05 06:00 [pubmed]
PHST- 2017/10/07 06:00 [medline]
AID - S1935-861X(16)30100-0 [pii]
AID - 10.1016/j.brs.2016.05.004 [doi]
PST - ppublish
SO  - Brain Stimul. 2016 Sep-Oct;9(5):671-681. doi: 10.1016/j.brs.2016.05.004. Epub 
      2016 May 16.