Evidence map›Paper›PMID 25983531›Full record

ArticleClinical research and regulatory affairs2015

Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel.

F Fregni, M A Nitsche, C K Loo, A R Brunoni, P Marangolo, J Leite, S Carvalho, N Bolognini, W Caumo, N J Paik and 12 more

5 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical research and regulatory affairs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 130 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05539131 nacompletednot on this mapstarted 2022, after this paper: background citation

Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields

TypeinterventionalSponsorYonsei UniversityRan2022 to 2024Enrolled198ConditionsDepressionArmstranscranial direct current stimulation (tDCS)
NCT05762796 narecruitingnot on this mapstarted 2024, after this paper: background citation

Assessing the Efficacy of Alterations in Subcortical-Cortical Functional Connectivity From Transcranial Direct Current Stimulation in Older Children After Mild Traumatic Brain Injury

TypeinterventionalSponsorState University of New York at BuffaloRan2024 to 2027Enrolled10ConditionsBrain Concussion, Mild Traumatic Brain Injury, Motor Disorders, Cognitive ImpairmentArmstDCS in Youth with mild traumatic brain injury
NCT05845164 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Impulsivity Mediation Using Transcranial Direct Current Stimulation Paired With Acceptance Commitment Therapy as an Adjunctive Therapy for Substance Use Disorder

TypeinterventionalSponsorUniversity of ArizonaRan2023 to 2023Enrolled30ConditionsSubstance Use Disorders, Substance Abuse, Substance UseArmstDCS, tDCS Sham
NCT05863494 naunknown statusnot on this mapstarted 2023, after this paper: background citation

Toward Personalized Treatment of Chronic Pain Using Transcranial Direct Current Stimulation Paired With Deep Learning

TypeinterventionalSponsorUniversity of ArizonaRan2023 to 2023Enrolled40ConditionsChronic PainArmsTranscranial Direct Current Stimulation (tDCS), Transcranial Direct Current Stimulation (tDCS) sham
NCT07303998 narecruitingnot on this mapstarted 2025, after this paper: background citation

Feasibility and Effect of Remotely Supervised Transcranial Direct Current Stimulation With Chair Yoga for Chronic Knee Pain Management in Older Adults With Alzheimer's Disease and Related Dementias.

TypeinterventionalSponsorUniversity of ArizonaRan2025 to 2026Enrolled40ConditionsAlzheimer&Amp, #39, s Disease, Other DementiasArmsActive tDCS paired with active online chair yoga
3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Digitalized transcranial electrical stimulation: A consensus statement.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2022
    Pooled it
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  11. Clinical study on swallowing function of brainstem stroke by tDCS.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2022
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70 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

F FregniSpaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA.
M A NitscheDepartment of Clinical Neurophysiology, Georg-August-University, Göttingen, Germany.
C K LooSchool of Psychiatry & The Black Dog Institute, University of New South Wales, Sydney, Australia.
A R BrunoniService of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo, Brazil.
P MarangoloDepartment of Experimental and Clinical Medicine, University Politecnica delle Marche, Ancona, and IRCCS Fondazione Santa Lucia, Roma, Italy.
J LeiteSpaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA ; Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga, Portugal.
S CarvalhoSpaulding Neuromodulation Center, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, MA ; Neuropsychophysiology Laboratory, CIPsi, School of Psychology (EPsi), University of Minho, Campus de Gualtar, Braga, Portugal.
N BologniniDepartment of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCC Instituto Auxologico Italiano, Milano, Italy.
W CaumoLaboratory of Pain & Neuromodulation at Hospital de Clínicas de Porto Alegre at UFRGS.
N J PaikDepartment of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seoul, South Korea.
M SimisService of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil and Division of Neurology, Santa Casa Medicak School, Sao Paulo, Brazil.
K UedaNational Cardiovascular Center, Osaka, Japan.
H EkhitariTranslational Neuroscience Program, Institute for Cognitive Science Studies, Tehran, Iran ; Neurocognitive Laboratory, Iranian National Center for Addiction Studies, Tehran University of Medical Sciences, Tehran, Iran.
P LuuElectrical Geodesics, Inc., and University of Oregon, Eugene, Oregon, USA.
D M TuckerElectrical Geodesics, Inc., and University of Oregon, Eugene, Oregon, USA.
W J TylerVirginia Tech Carilion Research Institute, Department of Psychiatry and Behavioral Medicine, Virginia Tech Carilion School of Medicine, and School of Biomedical Engineering and Sciences, Virginia Tech, Roanoke, VA USA.
J BrunelinEA 4615, Centre Hospitalier le Vinatier, Université de Lyon, F-69003, Université Claude Bernard Lyon I, Bron, France.
A DattaDepartment of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY, USA.
C H JuanInstitute of Cognitive Neuroscience, National Central University, Taiwan.
G VenkatasubramanianTranslational Psychiatry Laboratory, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore, India.
P S BoggioSocial and Cognitive Neuroscience Laboratory and Developmental Disorders Program, Center for Healthy and Biological Sciences, Mackenzie Presbyterian University, Sao Paulo, Brazil.
M BiksonDepartment of Biomedical Engineering, Neural Engineering Laboratory, The City College of the City University of New York New York, NY, USA.

Funding

Noninvasive Neural Stimulation TechnologyR44NS080632 · NINDS · HIGHLAND INSTRUMENTS, INC. · PI WAGNER, TIMOTHY ANDREW · 2012 to 2015
$3.0M
NINDS NIH HHS R44 NS080632Wellcome Trust
6 · The paper itself

Abstract

The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials.

Identifiers

PMID25983531
PMCPMC4431691

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.