Bilateral Prefrontal Modulation in Alcoholism (tDCS_ALCOHOL)

June 28, 2019 updated by: Ester Miyuki Nakamura-Palacios, Federal University of Espirito Santo

Prefrontal Modulation by Repetitive Bilateral Transcranial Direct Current Stimulation (tDCS) in Alcoholic Inpatients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • ES - Espírito Santo
      • Vitória, ES - Espírito Santo, Brazil, 29060-720
        • Federal University of Espirito Santo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: real tDCS
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).
Device: transcranial Direct Current Stimulation
Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes.
Other Names:
  • tDCS
Sham Comparator: sham-tDCS
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.
Device: transcranial Direct Current Stimulation
Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes.
Other Names:
  • tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Craving
Time Frame: 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.
Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20. Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Frontal Assessment Battery (FAB) Scores
Time Frame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
The FAB was used to explore six different domains of executive function. Each of these items is scored from 0 (zero) to a maximum of 3. Thus, the maximum score, meaning better scores, of FAB is 18. A single well trained examiner administered this assessment.
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Changes in Mini-Mental Status Examination (MMSE)
Time Frame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
An adapted version of the MMSE in Portuguese was used. This version included an 11-item examination that examined five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score, meaning better scores, that could be achieved was 30, while a mean score between 23 and 26 or between 26 and 29 would be expected according to the age and educational level of the alcoholics.
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Changes in Hamilton Depression Rating Scale (HAM-D)
Time Frame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
A structured multiple-choice questionnaire was used to assess the severity of depression symptoms. This instrument assesses the severity of symptoms observed in depression, such as low mood, insomnia, agitation, anxiety and weight loss (Hamilton, 1960). Each question has between 3 and 5 possible answers that increase in severity. In the original scale, the first 17 questions contribute to the total score, while questions 18 to 21 provide additional information about depression (e.g., diurnal variation, paranoid symptoms), but are not included in the total score of the scale. Scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score is 52.
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Changes in Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
A structured multiple-choice questionnaire designed to assess the severity of anxiety symptoms was employed. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (e.g., mental agitation and psychological distress) and somatic anxiety (e.g., physical complaints related to anxiety). The higher the scores, higher the severity. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where below 17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Changes in Event-Related Potentials (ERPs)
Time Frame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)

Electrophysiological recording was obtained through a 32-channel system placed on the scalp according to the International 10/20 EEG system.

A cue-reactivity paradigm was adapted following standard cue-reactivity paradigms well established for pictures and videos. During picture presentation the subjects were asked to press a button whenever the drug-related pictures were presented, and to withhold the response when the neutral pictures were presented (50% of the time). The percent change of ventral medial Prefrontal Cortex current density was analyzed.
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Changes in Quality of Life of the World Health Organization (WHOQOL-BREF)
Time Frame: Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
An abbreviated instrument of cross-culturally valid assessment of quality of life of the World Health Organization (WHOQOL-BREF) with 26 questions translated to Portuguese was applied at the beginning and at the end of the five-week treatment. This instrument yields four domains (physical health, psychological, social relationships and environment) and two individually scored items regarding overall perception of quality of life (Q1, i.e., first question) and health (Q2, i.e., second question). The four domain scores are scaled in a way that higher scores stand for higher quality of life. These scores were transformed to be comparable with the scores used in the WHOQOL-100.
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Espirito Santo

Collaborators

Harvard Medical School (HMS and HSDM)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
University of Göttingen

Investigators

  • Study Director: Ester MN Palacios, MD, PhD, Federal University of Espirito Santo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2013

Primary Completion (Actual)

July 3, 2018

Study Completion (Actual)

July 3, 2018

Study Registration Dates

First Submitted

March 16, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

June 28, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS ALCOHOL CEP_UFES 384281
  • CNPq_ 475232/2013-5 (Other Grant/Funding Number: CNPq process # 475232/2013-5)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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