Cranial Electrical Stimulation

Mindes, Janet; Dubin, Marc G.; Altemus, Margaret

doi:10.1007/978-1-4939-1408-1_11

Cited by 4 publications

(2 citation statements)

References 117 publications

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“…The presumed mechanisms of TES and the efficacy of TES in eliciting desired outcomes are not relevant for the scope of this review except for instances, in which they inform about safety. Other stimulation methods that are applying specific (brand) waveforms or conditions, such as cranial electrical stimulation (CES) are also not incorporated here, but have been comprehensively reviewed by other authors (Mindes et al, 2015). We also present recent regulatory issues and recommend rules for reporting in research and clinical practice, and finally we summarize existing data and provide recommendations for future safety monitoring.…”

Section: Introductionmentioning

confidence: 99%

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

Antal

Alekseichuk

Bikson

et al. 2017

Clinical Neurophysiology

882

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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: Introductionmentioning

confidence: 99%

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

Antal

Alekseichuk

Bikson

et al. 2017

Clinical Neurophysiology

882

728

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“…Significant deactivation of the midline frontal and parietal regions, as well as changes in connectivity within the default mode network, were discovered by the researchers. Nonetheless, according to one study, the mechanisms of action of externally applied CES have been found in the limbic system (which is involved in emotional regulation and memory), as well as in the cingulate gyrus, insula, and prefrontal cortex (which is involved in pain processing; Taylor et al, 2013) by a variety of process including: transcranial and cranial nerve stimulation, pathways like cortical and subcortical region activation, effects on endogenous brain oscillations and cortical excitability, impact on neurotransmitters, hormones and endorphins, and impact on autonomic nervous system in the desired frequency (Mindes et al, 2014). Overall, it's unclear if CES has a single mechanism of action or whether clinical effects are caused by different methods of action of different CES devices in different disorders; therefore, more thorough research is needed to resolve these questions.…”

Section: Speculated Underlying Mechanismmentioning

confidence: 99%

Effectiveness of Low Frequency Noninvasive Brain Stimulation Therapy for Improving Neuropsychological and Neurophysiological Functions: A Systematic Review

Khan,

Saif,

Parveen

2023

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Introduction. Cranial electrotherapy stimulation (CES) is a technique used to address various mental disorders symptoms. However, it is recently concluded that the quality of clinical trials involving CES is not standardized and lacks sufficient evidence to support its use for improving mental health. The purpose of this study was to undertake a systematic examination of evidence of CES in improving mental health. Method. From inception to April 2022, systematic review was conducted using electronic databases MEDLINE (accessed via PubMed), CENTRAL (Cochrane Library Central Register of Controlled Trials), and Web of Science to retrieve relevant studies. Methodology of all the identified randomized controlled trials (RCTs) was assessed using an 11-point PEDro scale by two independent reviewers. Results. Sixteen RCTs were identified to be relevant and their characteristics were evaluated. Thirteen studies concluded CES has favorable effect on variety of mental disorders, particularly on anxiety and depressed symptoms in varied groups. Conclusions. While these positive effects were observed, limitations included insufficient detail about existing treatments, lack of using standardized objective outcome measures for quantifying mental health dysfunction, and uneven representation of CES limiting the generalizability and making it difficult to carry out the pooled quantification and meta-analysis. Despite its shortcomings, literature suggests that CES warrants more research.

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Peripheral Neuromodulation on the Refractory Headache Disorders

Láinez

García-Ull

2019

Peripheral Interventional Management in Headache

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Cranial Electrical Stimulation

Cited by 4 publications

References 117 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

Effectiveness of Low Frequency Noninvasive Brain Stimulation Therapy for Improving Neuropsychological and Neurophysiological Functions: A Systematic Review

Peripheral Neuromodulation on the Refractory Headache Disorders

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