Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial

Gall, Carolin; Schmidt, Sein; Schittkowski, Michael; Antal, Andrea; Ambrus, Géza Gergely; Paulus, Walter; Dannhauer, Moritz; Michalik, Romualda; Mante, A.; Bola, Michał; Lux, Anke; Kropf, Siegfried; Brandt, Stephan A.; Sabel, Bernhard A.

doi:10.1371/journal.pone.0156134

Cited by 102 publications

(91 citation statements)

References 40 publications

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“…60–90 min (Gall et al, 2016). To date, 760 patients with optic neuropathies, e.g., following stroke or with postchiasmatic lesions, have been treated in various clinical trials using this technology (Fedorov et al, 2011; Gall et al, 2013, 2010, 2016, 2011, 2015; Sabel et al, 2011; Schmidt et al, 2013). The most common AEs were skin sensations and irritation, headache, drowsiness, and sleep disturbances.…”

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

931

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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: 99%

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

Antal

Alekseichuk

Bikson

et al. 2017

Clinical Neurophysiology

931

728

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“…Alternating current stimulation was recently demonstrated in an interventional randomised clinical trial to result in a significant mean improvement in visual field versus sham-treatment controls [24.0 % ( n = 45) vs. 2.5 % ( n = 37)] in patients with optic neuropathy, which persisted at 2 month follow-up [60]. Together, these studies provide tantalising evidence to suggest that future glaucoma therapies lie beyond the retina as the primary site of action, instead targeting the whole visual pathway.…”

Section: Techniques For Monitoring Retinal Ganglion Cell Healthmentioning

confidence: 99%

Glaucoma: the retina and beyond

Davis¹,

Crawley

Pahlitzsch³

et al. 2016

Acta Neuropathol

234

151

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Over 60 million people worldwide are diagnosed with glaucomatous optic neuropathy, which is estimated to be responsible for 8.4 million cases of irreversible blindness globally. Glaucoma is associated with characteristic damage to the optic nerve and patterns of visual field loss which principally involves the loss of retinal ganglion cells (RGCs). At present, intraocular pressure (IOP) presents the only modifiable risk factor for glaucoma, although RGC and vision loss can continue in patients despite well-controlled IOP. This, coupled with the present inability to diagnose glaucoma until relatively late in the disease process, has led to intense investigations towards the development of novel techniques for the early diagnosis of disease. This review outlines our current understanding of the potential mechanisms underlying RGC and axonal loss in glaucoma. Similarities between glaucoma and other neurodegenerative diseases of the central nervous system are drawn before an overview of recent developments in techniques for monitoring RGC health is provided, including recent progress towards the development of RGC specific contrast agents. The review concludes by discussing techniques to assess glaucomatous changes in the brain using MRI and the clinical relevance of glaucomatous-associated changes in the visual centres of the brain.

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“…In trials where eye movement recording was not undertaken, improvement in visual field due to eye movements cannot be excluded (Reinhard et al., 2005; Schmielau & Wong, 2007). However, studies where eye movements were measured did confirm visual field recovery, arguing against the hypothesis that compensatory eye movements alone can explain vision recovery (Gall et al., 2016; Kasten, Bunzenthal, & Sabel, 2006). …”

Section: Resultsmentioning

confidence: 99%

Adaptation to poststroke visual field loss: A systematic review

Howard

Rowe

2018

Brain and Behavior

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AimTo provide a systematic overview of the factors that influence how a person adapts to visual field loss following stroke.MethodA systematic review was undertaken (data search period 1861–2016) inclusive of systematic reviews, randomized controlled trials, controlled trials, cohort studies, observational studies, and case controlled studies. Studies including adult subjects with hemifield visual field loss, which occured as a direct consequence of stroke, were included. Search terms included a range of MESH terms as well as alternative terms relating to stroke, visual field loss, visual functions, visual perception, and adaptation. Articles were selected by two authors independently, and data were extracted by one author, being verified by the second. All included articles were assessed for risk of bias and quality using checklists appropriate to the study design.ResultsForty‐seven articles (2,900 participants) were included in the overall review, categorized into two sections. Section one included seventeen studies where the reviewers were able to identify a factor they considered as likely to be important for the process of adaptation to poststroke visual field loss. Section two included thirty studies detailing interventions for visual field loss that the reviewers deemed likely to have an influence on the adaptation process. There were no studies identified which specifically investigated and summarized the factors that influence how a person adapts to visual field loss following stroke.ConclusionThere is a substantial amount of evidence that patients can be supported to compensate and adapt to visual field loss following stroke using a range of strategies and methods. However, this systematic review highlights the fact that many unanswered questions in the area of adaptation to visual field loss remain. Further research is required on strategies and methods to improve adaptation to aid clinicians in supporting these patients along their rehabilitation journey.

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Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial

Cited by 102 publications

References 40 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

Glaucoma: the retina and beyond

Adaptation to poststroke visual field loss: A systematic review

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