OBJECTIVES: : The use of noninvasive cortical electrical stimulation with weak currents has significantly increased in basic and clinical human studies. Initial, preliminary studies with this technique have shown encouraging results; however, the safety and tolerability of this method of brain stimulation have not been sufficiently explored yet. The purpose of our study was to assess the effects of direct current (DC) and alternating current (AC) stimulation at different intensities in order to measure their effects on cognition, mood, and electroencephalogram. METHODS: : Eighty-two healthy, right-handed subjects receivedactive and sham stimulation in a randomized order. We conducted 164 ninety-minute sessions ofelectrical stimulation in 4 different protocols to assess safety of (1) anodal DC of the dorsolateral prefrontal cortex (DLPFC); (2) cathodal DC of the DLPFC; (3) intermittent anodal DC of the DLPFC and; (4) AC on the zygomatic process. We used weak currents of 1 to 2 mA (for DC experiments) or 0.1 to 0.2 mA (for AC experiment). RESULTS: : We found no significant changes in electroencephalogram, cognition, mood, and pain between groups and a low prevalence of mild adverse effects (0.11% and 0.08% in the active and sham stimulation groups, respectively), mainly, sleepiness and mild headache that were equally distributed between groups. CONCLUSIONS: : Here, we show no neurophysiological or behavioral signs that transcranial DC stimulation or AC stimulation with weak currents induce deleterious changes when comparing active and sham groups. This study provides therefore additional information for researchers and ethics committees, adding important results to the safety pool of studies assessing the effects of cortical stimulation using weak electrical currents. Further studies in patients with neuropsychiatric disorders are warranted.
RCT Entities:
OBJECTIVES: : The use of noninvasive cortical electrical stimulation with weak currents has significantly increased in basic and clinical human studies. Initial, preliminary studies with this technique have shown encouraging results; however, the safety and tolerability of this method of brain stimulation have not been sufficiently explored yet. The purpose of our study was to assess the effects of direct current (DC) and alternating current (AC) stimulation at different intensities in order to measure their effects on cognition, mood, and electroencephalogram. METHODS: : Eighty-two healthy, right-handed subjects received active and sham stimulation in a randomized order. We conducted 164 ninety-minute sessions of electrical stimulation in 4 different protocols to assess safety of (1) anodal DC of the dorsolateral prefrontal cortex (DLPFC); (2) cathodal DC of the DLPFC; (3) intermittent anodal DC of the DLPFC and; (4) AC on the zygomatic process. We used weak currents of 1 to 2 mA (for DC experiments) or 0.1 to 0.2 mA (for AC experiment). RESULTS: : We found no significant changes in electroencephalogram, cognition, mood, and pain between groups and a low prevalence of mild adverse effects (0.11% and 0.08% in the active and sham stimulation groups, respectively), mainly, sleepiness and mild headache that were equally distributed between groups. CONCLUSIONS: : Here, we show no neurophysiological or behavioral signs that transcranial DC stimulation or AC stimulation with weak currents induce deleterious changes when comparing active and sham groups. This study provides therefore additional information for researchers and ethics committees, adding important results to the safety pool of studies assessing the effects of cortical stimulation using weak electrical currents. Further studies in patients with neuropsychiatric disorders are warranted.
Authors: A Antal; I Alekseichuk; M Bikson; J Brockmöller; A R Brunoni; R Chen; L G Cohen; G Dowthwaite; J Ellrich; A Flöel; F Fregni; M S George; R Hamilton; J Haueisen; C S Herrmann; F C Hummel; J P Lefaucheur; D Liebetanz; C K Loo; C D McCaig; C Miniussi; P C Miranda; V Moliadze; M A Nitsche; R Nowak; F Padberg; A Pascual-Leone; W Poppendieck; A Priori; S Rossi; P M Rossini; J Rothwell; M A Rueger; G Ruffini; K Schellhorn; H R Siebner; Y Ugawa; A Wexler; U Ziemann; M Hallett; W Paulus Journal: Clin Neurophysiol Date: 2017-06-19 Impact factor: 3.708
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Authors: Marom Bikson; Pnina Grossman; Chris Thomas; Adantchede Louis Zannou; Jimmy Jiang; Tatheer Adnan; Antonios P Mourdoukoutas; Greg Kronberg; Dennis Truong; Paulo Boggio; André R Brunoni; Leigh Charvet; Felipe Fregni; Brita Fritsch; Bernadette Gillick; Roy H Hamilton; Benjamin M Hampstead; Ryan Jankord; Adam Kirton; Helena Knotkova; David Liebetanz; Anli Liu; Colleen Loo; Michael A Nitsche; Janine Reis; Jessica D Richardson; Alexander Rotenberg; Peter E Turkeltaub; Adam J Woods Journal: Brain Stimul Date: 2016-06-15 Impact factor: 8.955