Bilateral Prefrontal Modulation in Alcoholism (tDCS_ALCOHOL)

Federal University of Espirito Santo

Status: Completed

Conditions: Executive Dysfunction; Drug Addiction

Treatments: Device: transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02091284

tDCS ALCOHOL CEP_UFES 384281

CNPq_ 475232/2013-5 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 2 patient groups

real tDCS

Experimental group

Description:

Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).

Treatment:

Device: transcranial Direct Current Stimulation

sham-tDCS

Sham Comparator group

Description:

Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 20 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.

Treatment:

Device: transcranial Direct Current Stimulation