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Safety and Blinding of Transcranial Direct Current Stimulation in Schizophrenia Patients.

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Title: Safety and Blinding of Transcranial Direct Current Stimulation in Schizophrenia Patients.
Authors: Wysokiński A; Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz, Poland., Pazdrak Md M, Mazerant-Zielińska A, Szczakowska A
Source: The journal of ECT [J ECT] 2026 Sep 01; Vol. 42 (3), pp. e39-e45. Date of Electronic Publication: 2026 Sep 10.
Publication Type: Journal Article
Language: English
Journal Info: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 9808943 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1533-4112 (Electronic) Linking ISSN: 10950680 NLM ISO Abbreviation: J ECT Subsets: MEDLINE
Imprint Name(s): Publication: Hagerstown, MD : Lippincott Williams & Wilkins
Original Publication: Hagerstown, MD : Lippincott-Raven Publishers, c1998-
MeSH Terms: Transcranial Direct Current Stimulation*/adverse effects , Transcranial Direct Current Stimulation*/methods , Schizophrenia*/therapy, Humans ; Female ; Adult ; Male ; Middle Aged ; Young Adult ; Double-Blind Method
Abstract: Introduction: Transcranial direct current stimulation (tDCS) is a method of noninvasive brain stimulation. tDCS clinical efficacy is debatable, but it was proved to be effective at the neurophysiological level. tDCS has a very good safety profile in human subjects. Because the method has been more frequently studied in patients with schizophrenia, we wanted to analyze the safety and tolerability of tDCS treatment in this population. We also evaluated blinding quality of tDCS stimulations.
Material and Methods: All stimulations were performed using the DC-Stimulator PLUS (neuroCare, Germany) with the sham module installed. For all the stimulations, 2.0-mA current and 5 × 7-cm anode and cathode rubber electrodes in saline-soaked sponges were used.
Results: We collected and evaluated safety data in a large dataset of 1139 tDCS stimulations in patients with schizophrenia. No serious adverse events were recorded. None of the subjects discontinued tDCS treatment due to side effects. All the reported events resolved spontaneously within 30 minutes after the tDCS session. In approximately 17% of all the stimulations, no side effects were reported by the patients. The 2 most frequent types of side effects were itching/tingling (reported by 68.4% of the subjects) and burning/warmth sensations (57.4%, when combined).
Discussion: This study confirms that tDCS is safe and well tolerated by patients with schizophrenia. The most frequent side effects are itching/tingling and burning/warmth sensations, all of low severity. We found that blinding of tDCS stimulations is imperfect. We recommend that blinding assessment become a routine part of sham-controlled tDCS studies.
(Copyright © 2025 Wolters Kluwer Health, LLC. All rights reserved.)
Competing Interests: The authors have no conflicts of interest or financial disclosures to report.
References: Cirillo G, Di Pino G, Capone F, et al. Neurobiological after-effects of non-invasive brain stimulation. Brain Stimul. 2017;10:1–18.
Nitsche MA, Müller-Dahlhaus F, Paulus W, et al. The pharmacology of neuroplasticity induced by non-invasive brain stimulation: building models for the clinical use of CNS active drugs. J Physiol. 2012;590:4641–4662.
Lefaucheur JP, Antal A, Ayache SS, et al. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017;128:56–92.
Nikolin S, Huggins C, Martin D, et al. Safety of repeated sessions of transcranial direct current stimulation: a systematic review. Brain Stimul. 2018;11:278–288.
Loo CK, Martin DM, Alonzo A, et al. Avoiding skin burns with transcranial direct current stimulation: preliminary considerations. Int J Neuropsychopharmacol. 2011;14:425–426.
Wang J, Wei Y, Wen J, et al. Skin burn after single session of transcranial direct current stimulation (tDCS). Brain Stimul. 2015;8:165–166.
Bikson M, Grossman P, Thomas C, et al. Safety of transcranial direct current stimulation: evidence based update 2016. Brain Stimul. 2016;9:641–661.
Monaghan TF, Agudelo CW, Rahman SN, et al. Blinding in clinical trials: seeing the big picture. Medicina. 2021;57:647.
Kim J, Iwata Y, Plitman E, et al. A meta-analysis of transcranial direct current stimulation for schizophrenia: “is more better?”. J Psychiatr Res. 2019;110:117–126.
Bezanson J, Edelman A, Karpinski S, et al. Julia: a fresh approach to numerical computing. SIAM Rev. 2017;59:65–98.
James KE, Bloch DA, Lee KK, et al. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation—a va cooperative study. Stat Med. 1996;15:1421–1434.
Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25:143–156.
Seeck M, Koessler L, Bast T, et al. The standardized EEG electrode array of the IFCN. Clin Neurophysiol. 2017;128:2070–2077.
Wysokiński A. Tolerability and safety of 219 transcranial direct current stimulation (TDCS) 2.0 mA sessions in adult patients with schizophrenia. Psychiatr Danub. 2023;35:33–37.
Lévesque M, Potvin S, Marchand S, et al. Pain perception in schizophrenia: evidence of a specific pain response profile. Pain Med. 2012;13:1571–1579.
Chhabra H, Bose A, Shivakumar V, et al. Tolerance of transcranial direct current stimulation in psychiatric disorders: an analysis of 2000+ sessions. Psychiatry Res. 2020;284:112744.
Poreisz C, Boros K, Antal A, et al. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007;72(4–6):208–214.
Workman CD, Fietsam AC, Kamholz J, et al. Women report more severe sensations from 2 mA and 4 mA transcranial direct current stimulation than men. Eur J Neurosci. 2021;53:2696–2702.
Aslaksen PM, Vasylenko O, Fagerlund AJ. The effect of transcranial direct current stimulation on experimentally induced heat pain. Exp Brain Res. 2014;232:1865–1873.
Kolahi J, Bang H, Park J. Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. Community Dent Oral Epidemiol. 2009;37:477–484.
De Smet S, Nikolin S, Moffa A, et al. Determinants of sham response in tDCS depression trials: a systematic review and meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2021;109:110261.
Stanković M, Živanović M, Bjekić J, et al. Blinding in tDCS studies: correct end-of-study guess does not moderate the effects on associative and working memory. Brain Sci. 2021;12:58.
Turi Z, Csifcsák G, Boayue NM, et al. Blinding is compromised for transcranial direct current stimulation at 1 mA for 20 min in young healthy adults. Eur J Neurosci. 2019;50:3261–3268.
Turner C, Jackson C, Learmonth G. Is the “end-of-study guess” a valid measure of sham blinding during transcranial direct current stimulation? Eur J Neurosci. 2021;53:1592–1604.
Fonteneau C, Mondino M, Arns M, et al. Sham tDCS: a hidden source of variability? Reflections for further blinded, controlled trials. Brain Stimul. 2019;12:668–673.
Contributed Indexing: Keywords: blinding; safety; schizophrenia; tDCS; transcranial direct current stimulation
Entry Date(s): Date Created: 20250414 Date Completed: 20260911 Latest Revision: 20260911
Update Code: 20260912
DOI: 10.1097/YCT.0000000000001148
PMID: 40228176
Database: MEDLINE
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  Data: Safety and Blinding of Transcranial Direct Current Stimulation in Schizophrenia Patients.
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  Data: <searchLink fieldCode="AU" term="%22Wysokiński+A%22">Wysokiński A</searchLink>; Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz, Poland.<br /><searchLink fieldCode="AU" term="%22Pazdrak+Md+M%22">Pazdrak Md M</searchLink><br /><searchLink fieldCode="AU" term="%22Mazerant-Zielińska+A%22">Mazerant-Zielińska A</searchLink><br /><searchLink fieldCode="AU" term="%22Szczakowska+A%22">Szczakowska A</searchLink>
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  Data: <searchLink fieldCode="JN" term="%229808943%22">The journal of ECT</searchLink> [J ECT] 2026 Sep 01; Vol. 42 (3), pp. e39-e45. <i>Date of Electronic Publication: </i>2026 Sep 10.
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  Data: <searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation%22">Transcranial Direct Current Stimulation*</searchLink>/<searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation+adverse+effects%22">adverse effects</searchLink> <br /><searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation%22">Transcranial Direct Current Stimulation*</searchLink>/<searchLink fieldCode="MM" term="%22Transcranial+Direct+Current+Stimulation+methods%22">methods</searchLink> <br /><searchLink fieldCode="MM" term="%22Schizophrenia%22">Schizophrenia*</searchLink>/<searchLink fieldCode="MM" term="%22Schizophrenia+therapy%22">therapy</searchLink><br /><searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Female%22">Female</searchLink> ; <searchLink fieldCode="MH" term="%22Adult%22">Adult</searchLink> ; <searchLink fieldCode="MH" term="%22Male%22">Male</searchLink> ; <searchLink fieldCode="MH" term="%22Middle+Aged%22">Middle Aged</searchLink> ; <searchLink fieldCode="MH" term="%22Young+Adult%22">Young Adult</searchLink> ; <searchLink fieldCode="MH" term="%22Double-Blind+Method%22">Double-Blind Method</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Introduction: Transcranial direct current stimulation (tDCS) is a method of noninvasive brain stimulation. tDCS clinical efficacy is debatable, but it was proved to be effective at the neurophysiological level. tDCS has a very good safety profile in human subjects. Because the method has been more frequently studied in patients with schizophrenia, we wanted to analyze the safety and tolerability of tDCS treatment in this population. We also evaluated blinding quality of tDCS stimulations.<br />Material and Methods: All stimulations were performed using the DC-Stimulator PLUS (neuroCare, Germany) with the sham module installed. For all the stimulations, 2.0-mA current and 5 × 7-cm anode and cathode rubber electrodes in saline-soaked sponges were used.<br />Results: We collected and evaluated safety data in a large dataset of 1139 tDCS stimulations in patients with schizophrenia. No serious adverse events were recorded. None of the subjects discontinued tDCS treatment due to side effects. All the reported events resolved spontaneously within 30 minutes after the tDCS session. In approximately 17% of all the stimulations, no side effects were reported by the patients. The 2 most frequent types of side effects were itching/tingling (reported by 68.4% of the subjects) and burning/warmth sensations (57.4%, when combined).<br />Discussion: This study confirms that tDCS is safe and well tolerated by patients with schizophrenia. The most frequent side effects are itching/tingling and burning/warmth sensations, all of low severity. We found that blinding of tDCS stimulations is imperfect. We recommend that blinding assessment become a routine part of sham-controlled tDCS studies.<br /> (Copyright © 2025 Wolters Kluwer Health, LLC. All rights reserved.)
– Name: Abstract
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  Data: The authors have no conflicts of interest or financial disclosures to report.
– Name: Ref
  Label: References
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  Data: Cirillo G, Di Pino G, Capone F, et al. Neurobiological after-effects of non-invasive brain stimulation. Brain Stimul. 2017;10:1–18.<br />Nitsche MA, Müller-Dahlhaus F, Paulus W, et al. The pharmacology of neuroplasticity induced by non-invasive brain stimulation: building models for the clinical use of CNS active drugs. J Physiol. 2012;590:4641–4662.<br />Lefaucheur JP, Antal A, Ayache SS, et al. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017;128:56–92.<br />Nikolin S, Huggins C, Martin D, et al. Safety of repeated sessions of transcranial direct current stimulation: a systematic review. Brain Stimul. 2018;11:278–288.<br />Loo CK, Martin DM, Alonzo A, et al. Avoiding skin burns with transcranial direct current stimulation: preliminary considerations. Int J Neuropsychopharmacol. 2011;14:425–426.<br />Wang J, Wei Y, Wen J, et al. Skin burn after single session of transcranial direct current stimulation (tDCS). Brain Stimul. 2015;8:165–166.<br />Bikson M, Grossman P, Thomas C, et al. Safety of transcranial direct current stimulation: evidence based update 2016. Brain Stimul. 2016;9:641–661.<br />Monaghan TF, Agudelo CW, Rahman SN, et al. Blinding in clinical trials: seeing the big picture. Medicina. 2021;57:647.<br />Kim J, Iwata Y, Plitman E, et al. A meta-analysis of transcranial direct current stimulation for schizophrenia: “is more better?”. J Psychiatr Res. 2019;110:117–126.<br />Bezanson J, Edelman A, Karpinski S, et al. Julia: a fresh approach to numerical computing. SIAM Rev. 2017;59:65–98.<br />James KE, Bloch DA, Lee KK, et al. An index for assessing blindness in a multi-centre clinical trial: disulfiram for alcohol cessation—a va cooperative study. Stat Med. 1996;15:1421–1434.<br />Bang H, Ni L, Davis CE. Assessment of blinding in clinical trials. Control Clin Trials. 2004;25:143–156.<br />Seeck M, Koessler L, Bast T, et al. The standardized EEG electrode array of the IFCN. Clin Neurophysiol. 2017;128:2070–2077.<br />Wysokiński A. Tolerability and safety of 219 transcranial direct current stimulation (TDCS) 2.0 mA sessions in adult patients with schizophrenia. Psychiatr Danub. 2023;35:33–37.<br />Lévesque M, Potvin S, Marchand S, et al. Pain perception in schizophrenia: evidence of a specific pain response profile. Pain Med. 2012;13:1571–1579.<br />Chhabra H, Bose A, Shivakumar V, et al. Tolerance of transcranial direct current stimulation in psychiatric disorders: an analysis of 2000+ sessions. Psychiatry Res. 2020;284:112744.<br />Poreisz C, Boros K, Antal A, et al. Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients. Brain Res Bull. 2007;72(4–6):208–214.<br />Workman CD, Fietsam AC, Kamholz J, et al. Women report more severe sensations from 2 mA and 4 mA transcranial direct current stimulation than men. Eur J Neurosci. 2021;53:2696–2702.<br />Aslaksen PM, Vasylenko O, Fagerlund AJ. The effect of transcranial direct current stimulation on experimentally induced heat pain. Exp Brain Res. 2014;232:1865–1873.<br />Kolahi J, Bang H, Park J. Towards a proposal for assessment of blinding success in clinical trials: up-to-date review. Community Dent Oral Epidemiol. 2009;37:477–484.<br />De Smet S, Nikolin S, Moffa A, et al. Determinants of sham response in tDCS depression trials: a systematic review and meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2021;109:110261.<br />Stanković M, Živanović M, Bjekić J, et al. Blinding in tDCS studies: correct end-of-study guess does not moderate the effects on associative and working memory. Brain Sci. 2021;12:58.<br />Turi Z, Csifcsák G, Boayue NM, et al. Blinding is compromised for transcranial direct current stimulation at 1 mA for 20 min in young healthy adults. Eur J Neurosci. 2019;50:3261–3268.<br />Turner C, Jackson C, Learmonth G. Is the “end-of-study guess” a valid measure of sham blinding during transcranial direct current stimulation? Eur J Neurosci. 2021;53:1592–1604.<br />Fonteneau C, Mondino M, Arns M, et al. Sham tDCS: a hidden source of variability? Reflections for further blinded, controlled trials. Brain Stimul. 2019;12:668–673.
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      – SubjectFull: Transcranial Direct Current Stimulation methods
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      – SubjectFull: Schizophrenia therapy
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              Text: 2026 Sep 01
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