Clinical trial NCT02091284: Bilateral Prefrontal Modulation in Alcoholism
Official title: Prefrontal Modulation by Repetitive Bilateral Transcranial Direct Current Stimulation (tDCS) in Alcoholic Inpatients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Addiction
Executive Dysfunction
Keywords: alcoholism
tDCS
dlPFC
craving
cognition
Lead sponsor: Federal University of Espirito Santo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Harvard Medical School (HMS and HSDM)
name: University of Göttingen
First posted: 2014-03-19
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sham-controlled double-blind randomized trial
Primary purpose: TREATMENT

Brief summary: In this study, eligible alcoholic inpatients recruited from a specialized clinic for addiction treatment, filling inclusion criteria and not showing any exclusion criteria, were randomized to receive the repetitive (10 sessions, every other day) bilateral dorsolateral Prefrontal Cortex (dlPFC: cathodal left / anodal right) tDCS (2 milliamperes, 5 x 7 cm2, for 20 min) or placebo (sham-tDCS). Craving to the use of alcohol was examined before (baseline), during and after the end of the tDCS treatment.

Based in our previous data, our hypothesis was that repetitive bilateral tDCS over dlPFC would favorably change craving in alcoholism and this would be a long-lasting effect.

Detailed description: Before (baseline) and after tDCS or sham-tDCS treatment, subjects were clinically examined regarding craving (obsessive compulsive drinking scale) and they were followed-up for relapses at least 3 months after treatment.

Eligibility criteria: Inclusion Criteria:

* patients between the age of 18 and 60 years;
* met criteria for alcohol dependence according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), as determined by clinical evaluation;
* in stable clinical condition with no need for inpatient care;
* able to read, write, and speak Portuguese; and
* no severe withdrawal signs or symptoms at baseline.

Exclusion Criteria:

* a condition of intoxication or withdrawal due to a substance other alcohol;
* unstable mental or medical disorder or substance abuse or addiction other than alcohol dependence, except nicotine and/or caffeine;
* a diagnosis of epilepsy, convulsions, or delirium tremens during abstinence from alcohol;
* a previous history of drug hypersensitivity or adverse reactions to diazepam or other benzodiazepines and haloperidol;
* any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants;
* suspected pregnancy for female participants;
* any contraindication for magnetic resonance procedures such as electronic implants, metal implants, claustrophobia, or permanent make-up or tattoo received within the previous 3 months;
* the presence of vascular, traumatic, inflammatory, or tumor injuries detectable by CT examination.

Primary outcomes:
measure: Craving
timeFrame: Five applications: first week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fifth week, after the end of the tDCS treatment.
Secondary outcomes:
Other outcomes:
measure: Changes in Frontal Assessment Battery (FAB) Scores
timeFrame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
measure: Changes in Mini-Mental Status Examination (MMSE)
timeFrame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
measure: Changes in Hamilton Depression Rating Scale (HAM-D)
timeFrame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
measure: Changes in Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
measure: Changes in Event-Related Potentials (ERPs)
timeFrame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
measure: Changes in Quality of Life of the World Health Organization (WHOQOL-BREF)
timeFrame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Locations:
city: Vitória
country: Brazil
facility: Federal University of Espírito Santo
state: ES - Espírito Santo
Study officials:
affiliation: Federal University of Espírito Santo
name: Ester MN Palacios, MD, PhD
role: STUDY_DIRECTOR
References:
citation: da Silva MC, Conti CL, Klauss J, Alves LG, do Nascimento Cavalcante HM, Fregni F, Nitsche MA, Nakamura-Palacios EM. Behavioral effects of transcranial direct current stimulation (tDCS) induced dorsolateral prefrontal cortex plasticity in alcohol dependence. J Physiol Paris. 2013 Dec;107(6):493-502. doi: 10.1016/j.jphysparis.2013.07.003. Epub 2013 Jul 25.
citation: Nakamura-Palacios EM, Souza RS, Zago-Gomes MP, de Melo AM, Braga FS, Kubo TT, Gasparetto EL. Gray matter volume in left rostral middle frontal and left cerebellar cortices predicts frontal executive performance in alcoholic subjects. Alcohol Clin Exp Res. 2014 Apr;38(4):1126-33. doi: 10.1111/acer.12308. Epub 2013 Nov 20.
citation: Klauss J, Penido Pinheiro LC, Silva Merlo BL, de Almeida Correia Santos G, Fregni F, Nitsche MA, Miyuki Nakamura-Palacios E. A randomized controlled trial of targeted prefrontal cortex modulation with tDCS in patients with alcohol dependence. Int J Neuropsychopharmacol. 2014 Nov;17(11):1793-803. doi: 10.1017/S1461145714000984. Epub 2014 Jul 10.
citation: Klauss J, Anders QS, Felippe LV, Nitsche MA, Nakamura-Palacios EM. Multiple Sessions of Transcranial Direct Current Stimulation (tDCS) Reduced Craving and Relapses for Alcohol Use: A Randomized Placebo-Controlled Trial in Alcohol Use Disorder. Front Pharmacol. 2018 Jul 3;9:716. doi: 10.3389/fphar.2018.00716. eCollection 2018.