title: A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence.
abstract: Preliminary small studies have shown that transcranial direct current stimulation (tDCS) reduces craving in alcoholic subjects. It is unclear whether tDCS also leads to changes in clinically meaningful outcomes for alcohol dependence in a properly powered phase II randomized clinical trial. We aimed to investigate whether repetitive tDCS changes the risk of alcohol use relapse in severe alcoholics from outpatient services. Thirty-five subjects were randomized to receive active bilateral [left cathodal/right anodal over the dorsolateral prefrontal cortex (dlPFC)] repetitive (five consecutive days) tDCS (2 mA, 35 cm2, two times daily stimulation for 13 min with a 20-min interval) or sham-tDCS. There were two dropouts before treatment. From 33 alcoholic subjects, 17 (mean age 45.5±8.9 s.d., 16 males) were randomized to sham and 16 (44±7.8 s.d., 16 males) to real tDCS treatment. By the end of the six months of follow-up, two subjects treated with sham (11.8%) and eight treated with real tDCS (50%) were still alcohol-abstinent [p=0.02, Long-rank (Mantel-Cox) Test, HR=0.35 (95% CI, 0.14-0.85)]. No differences with regard to changes on scores of craving, frontal function, global mental status, depressive or anxiety symptoms were observed between groups. However, subjects from the tDCS group improved with regard to their overall perception of quality of life (p=0.02), and increased their scores in the environment domain (p=0.04) after treatment. Bilateral tDCS over dlPFC reduces relapse probability in severe alcoholic subjects and results in improved perception of quality of life.
authors.affiliation: Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Postgraduation in Physiological Sciences,Federal University of Espírito Santo,Vitória-ES,Brazil.
authors.forename: Jaisa
authors.initials: J
authors.lastname: Klauss
authors.affiliation: Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Postgraduation in Physiological Sciences,Federal University of Espírito Santo,Vitória-ES,Brazil.
authors.forename: Leon Cleres
authors.initials: LC
authors.lastname: Penido Pinheiro
authors.affiliation: Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Postgraduation in Physiological Sciences,Federal University of Espírito Santo,Vitória-ES,Brazil.
authors.forename: Bruna Lima
authors.initials: BL
authors.lastname: Silva Merlo
authors.affiliation: Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Postgraduation in Physiological Sciences,Federal University of Espírito Santo,Vitória-ES,Brazil.
authors.forename: Gerson
authors.initials: G
authors.lastname: de Almeida Correia Santos
authors.affiliation: Laboratory of Neuromodulation, Department of Physical Medicine & Rehabilitation and Massachusetts General Hospital, Spauding Rehabilitation Hospital,Harvard Medical School,Boston, MA,USA.
authors.forename: Felipe
authors.initials: F
authors.lastname: Fregni
authors.affiliation: Laboratory of Neuroplasticity, Department of Clinical Neurophysiology,University Medical Centre, Georg-August-University,Göttingen,Germany.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Nitsche
authors.affiliation: Laboratory of Cognitive Sciences and Neuropsychopharmacology, Program of Postgraduation in Physiological Sciences,Federal University of Espírito Santo,Vitória-ES,Brazil.
authors.forename: Ester
authors.initials: E
authors.lastname: Miyuki Nakamura-Palacios
mesh_terms: D000328:Adult; D000437:Alcoholism / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017397:Prefrontal Cortex / Q000502:physiology*; D016016:Proportional Hazards Models; D011569:Psychiatric Status Rating Scales; D065908:Transcranial Direct Current Stimulation; D016896:Treatment Outcome