TY - JOUR
T1 - Safety of Transcranial Direct Current Stimulation
T2 - Evidence Based Update 2016
AU - Bikson, Marom
AU - Grossman, Pnina
AU - Thomas, Chris
AU - Zannou, Adantchede Louis
AU - Jiang, Jimmy
AU - Adnan, Tatheer
AU - Mourdoukoutas, Antonios P.
AU - Kronberg, Greg
AU - Truong, Dennis
AU - Boggio, Paulo
AU - Brunoni, André R.
AU - Charvet, Leigh
AU - Fregni, Felipe
AU - Fritsch, Brita
AU - Gillick, Bernadette
AU - Hamilton, Roy H.
AU - Hampstead, Benjamin M.
AU - Jankord, Ryan
AU - Kirton, Adam
AU - Knotkova, Helena
AU - Liebetanz, David
AU - Liu, Anli
AU - Loo, Colleen
AU - Nitsche, Michael A.
AU - Reis, Janine
AU - Richardson, Jessica D.
AU - Rotenberg, Alexander
AU - Turkeltaub, Peter E.
AU - Woods, Adam J.
N1 - Publisher Copyright:
© 2016 Elsevier Inc.
PY - 2016/9/1
Y1 - 2016/9/1
N2 - This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose–response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3–13 A/m2) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
AB - This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose–response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3–13 A/m2) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
KW - Electrical stimulation
KW - Mood disorders
KW - Safety
KW - Transcranial Direct Current Stimulation
KW - tDCS
KW - tDCS safety
UR - http://www.scopus.com/inward/record.url?scp=84977638390&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84977638390&partnerID=8YFLogxK
U2 - 10.1016/j.brs.2016.06.004
DO - 10.1016/j.brs.2016.06.004
M3 - Review article
C2 - 27372845
AN - SCOPUS:84977638390
SN - 1935-861X
VL - 9
SP - 641
EP - 661
JO - Brain Stimulation
JF - Brain Stimulation
IS - 5
ER -