A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials

Aparicio, Luana V Marotti; Guarienti, Fabiana Amaral; Razza, Laís B.; Carvalho, André F.; Fregni, Felipe; Brunoni, André R.

doi:10.1016/j.brs.2016.05.004

Cited by 138 publications

(93 citation statements)

References 92 publications

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“…The burden associated with TES in MDD trials was basically the same as in all other trials with tDCS, i.e., cutaneous symptoms and sensations occurring with the same frequency (Aparicio et al, 2016). Four RCTs (Bennabi et al, 2015; Brunoni et al, 2013b; Loo et al, 2012, 2010) described treatment-emergent mania/hypomania in a total of ten cases: nine in the active and one in the sham groups (Table 8).…”

Section: The Application Of Low Intensity Tes In Human Studies: Aementioning

confidence: 80%

“…For example, in MDD some RCTs (Brunoni et al, 2013b; Loo et al, 2012, 2010) actively surveyed for AEs, and therefore the reported AE prevalence was much higher compared to other RCTs (Bennabi et al, 2015; Blumberger et al, 2012; Palm et al, 2012). In fact, in a recent systematic review of 64 tDCS trials (Aparicio et al, 2016), it was found that the quality of AE reporting was quite low – MDD trials only complied with 31.3% of the items described by CONSORT-harms (a “gold-standard” questionnaire for adequate AE reporting). Lack of adequate AE reporting is a concern because this usually leads to an underestimation of the true rate of AEs, which can, in turn, result in safety and blinding issues.…”

Section: The Application Of Low Intensity Tes In Human Studies: Aementioning

confidence: 99%

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Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Antal

Alekseichuk

Bikson

et al. 2017

Clinical Neurophysiology

886

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Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2 mA and during tACS at higher peak-to-peak intensities above 2 mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity ‘conventional’ TES defined as <4 mA, up to 60 min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13 A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10 mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6–7, 2016 and were refined thereafter by email correspondence.

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Section: The Application Of Low Intensity Tes In Human Studies: Aementioning

confidence: 80%

Section: The Application Of Low Intensity Tes In Human Studies: Aementioning

confidence: 99%

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Antal

Alekseichuk

Bikson

et al. 2017

Clinical Neurophysiology

886

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“…Copyright ª 2017 National Strength and Conditioning Association tDCS and countermovement jump JSCR-08-8672 3 Although tDCS has been mainly used for patients with neurologic diseases (10,19,29) and psychiatric disorders (2), it also has been highlighted as a valuable tool to enhance physical exercise training (15,16). There have been several studies exploring the effects of tDCS on muscle strength of healthy subjects (15)(16)(17)28).…”

Section: A C C E P T E Dmentioning

confidence: 98%

Can Transcranial Direct Current Stimulation Improve Muscle Power in Individuals With Advanced Weight-Training Experience?

Lattari

Campos

Lamego

et al. 2020

Journal of Strength and Conditioning Research

108

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The aim of this study was to investigate the effects of transcranial direct current stimulation (tDCS) on countermovement jump performance (CMJ) in men with advanced strength training experience. Ten healthy male subjects, with advanced strength training and squatting exercise experience, were included. Participants took part in an initial visit to the laboratory to complete anthropometric measurements and CMJ kinematic test-retest reliability. Participants then completed three experimental conditions, 48-72 hours apart, in a randomized, double-blinded crossover design: anodal, cathodal and sham tDCS (2 mA for 20 minutes targeting the motor cortex bilaterally). Participants completed three CMJ tests before and after each experimental condition, with one-minute recovery interval between each test. The best CMJ in each moment was selected for analysis. Two-way (condition by moment) repeated measures ANOVA's were performed for CMJ height, flight time and muscular peak power. Effect sizes and interindividual variability of tDCS responses were also analyzed. There was a significant condition by moment interaction for all outcome measures, with a large pre-post increase in CMJ height, flight time and muscular peak power in the anodal condition. All the participants displayed CMJ performance improvements after the anodal condition. There were no significant differences in both cathodal and sham conditions. Anodal tDCS may be a valuable tool to enhance muscle power related tasks performance, which is extremely relevant for sports that require vertical jumping ability. Anodal tDCS may also be used to support strength training, enhancing its effects on performance-oriented outcome measures.

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“…Further, we carefully defined the scope of the review, “In this review, tDCS safety indicates the absence of a Serious Adverse Effect including brain tissue injury related to tDCS application.” We developed precise criteria for a Serious Adverse Effect. A systematic review of all adverse events, including minor side effects that may affect the acceptability and tolerability of tDCS (as suggested by Godhino et al) was outside the scope of our review, and addressed elsewhere including recently by our coauthors [2]. …”

Section: Dear Editormentioning

confidence: 99%

Response to letter to the editor: Safety of transcranial direct current stimulation: Evidence based update 2016

et al. 2017

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A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials

Cited by 138 publications

References 92 publications

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Can Transcranial Direct Current Stimulation Improve Muscle Power in Individuals With Advanced Weight-Training Experience?

Response to letter to the editor: Safety of transcranial direct current stimulation: Evidence based update 2016

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