Safety Review of Transcranial Direct Current Stimulation in Stroke

Russo, Cristina; Carneiro, Maíra Izzadora Souza; Bolognini, Nadia; Fregni, Felipe

doi:10.1111/ner.12574

Cited by 82 publications

(75 citation statements)

References 35 publications

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“…Our results are consistent with another review showing that 40.7% of the studies assessing treatment with tDCS in stroke patients fail to mention whether adverse effects were measured or not and whether they occurred or not (11). Therefore, the conclusion that there are no reports of serious adverse effects associated to tDCS could better represent an "absence of evidence of harms" rather than "evidence of absence of harms" (12).…”

Section: A C C E P T E D Accepted Manuscriptsupporting

confidence: 90%

Safety of transcranial direct current stimulation: Evidence based update 2016

et al. 2017

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Section: A C C E P T E D Accepted Manuscriptsupporting

confidence: 90%

Safety of transcranial direct current stimulation: Evidence based update 2016

et al. 2017

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“…Since this patient only received sham tDCS, this severe AE is unrelated to tDCS and does not change the safety of repeated tDCS in patients with DOC. Indeed, the few AE reported (13/946 tDCS sessions e 1%) refer to skin redness and sleepiness that both have been previously reported (no sign of pain or discomfort was reported) [23].…”

Section: Discussionmentioning

confidence: 74%

Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state

Martens¹,

et al. 2018

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a b s t r a c tBackground: Patients with chronic disorders of consciousness face a significant lack of treatment options. Objective: We aimed at investigating the feasibility and the behavioral effects of home-based transcranial direct current stimulation (tDCS), applied by relatives or caregivers, in chronic patients in minimally conscious state (MCS). Methods: Each participant received, in a randomized order, 20 sessions of active and 20 sessions of sham tDCS applied over the prefrontal cortex for 4 weeks; separated by 8 weeks of washout. Level of consciousness was assessed using the Coma Recovery Scale-Revised before the first stimulation (baseline), at the end of the 20 tDCS sessions (direct effects) and 8 weeks after the end of each stimulation period (long-term effects). Reported adverse events and data relative to the adherence (i.e., amount of sessions effectively received) were collected as well. Results: Twenty-seven patients completed the study and 22 patients received at least 80% of the stimulation sessions. All patients tolerated tDCS well, no severe adverse events were noticed after real stimulation and the overall adherence (i.e., total duration of stimulation) was good. A moderate effect size (0.47 and 0.53, for modified intention to treat and per protocol analysis, respectively) was observed at the end of the 4 weeks of tDCS in favor of the active treatment. Conclusions: We demonstrated that home-based tDCS can be used adequately outside a research facility or hospital by patients' relatives or caregivers. In addition, 4 weeks of tDCS moderately improved the recovery of signs of consciousness in chronic MCS patients.© 2018 Elsevier Inc. All rights reserved. IntroductionPatients who suffered from a severe brain injury and stay with a disorder of consciousness (DOC) represent a challenging population to treat since, by definition, these patients are unable to communicate, and therefore to participate in active rehabilitation programs. Currently, their treatment options are limited, especially in the chronic setting. Several drugs to improve the level of consciousness have been studied (e.g., zolpidem, levodopa or baclofen) [1]. However, so far, only amantadine showed significant clinical effects [2]. Recently, transcranial direct current stimulation (tDCS) showed promising results in patients in a minimally conscious state (MCS e i.e., showing fluctuating but reproducible signs of consciousness, such as response to command or visual pursuit for instance, while being unable to functionally communicate) while patients in unresponsive wakefulness syndrome (UWS e i.e., only showing cyclic eye-opening and reflexive behaviors) seem to be less responsive to that treatment. We demonstrated that a single session of tDCS, applied with the anode over the left dorsolateral prefrontal cortex (DLPFC) and the cathode over the contralateral supraorbital area, induced transient clinical improvement [4], as

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“…Indeed, about one third of tDCS clinical trials in stroke exclude patients with history of seizures and/or epilepsy (Russo et al, 2017). However there have been no cases of confirmed seizures induced by tDCS regardless of the risk of seizures.…”

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

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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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Safety Review of Transcranial Direct Current Stimulation in Stroke

Cited by 82 publications

References 35 publications

Safety of transcranial direct current stimulation: Evidence based update 2016

Safety of transcranial direct current stimulation: Evidence based update 2016

Randomized controlled trial of home-based 4-week tDCS in chronic minimally conscious state

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

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