Back to resultsBilateral Prefrontal Modulation in Alcoholism (tDCS_ALCOHOL)
Primary Purpose
Drug Addiction, Executive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Drug Addiction focused on measuring alcoholism, tDCS, dlPFC, craving, cognition
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.
Sites / Locations
- Federal University of Espírito Santo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
real tDCS
sham-tDCS
Arm 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).
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.
Outcomes
Primary Outcome Measures
Craving
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02091284
First Posted
March 16, 2014
Last Updated
June 28, 2019
Sponsor
Federal University of Espirito Santo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Harvard Medical School (HMS and HSDM), University of Göttingen
1. Study Identification
Unique Protocol Identification Number
NCT02091284
Brief Title
Bilateral Prefrontal Modulation in Alcoholism
Acronym
tDCS_ALCOHOL
Official Title
Prefrontal Modulation by Repetitive Bilateral Transcranial Direct Current Stimulation (tDCS) in Alcoholic Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
July 3, 2018 (Actual)
Study Completion Date
July 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Espirito Santo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Harvard Medical School (HMS and HSDM), University of Göttingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Addiction, Executive Dysfunction
Keywords
alcoholism, tDCS, dlPFC, craving, cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Sham-controlled double-blind randomized trial
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
real tDCS
Arm Type
Experimental
Arm 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).
Arm Title
sham-tDCS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Craving
Description
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.
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.
Other Pre-specified Outcome Measures:
Title
Changes in Frontal Assessment Battery (FAB) Scores
Description
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.
Time Frame
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Title
Changes in Mini-Mental Status Examination (MMSE)
Description
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.
Time Frame
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Title
Changes in Hamilton Depression Rating Scale (HAM-D)
Description
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.
Time Frame
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Title
Changes in Hamilton Anxiety Rating Scale (HAM-A)
Description
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.
Time Frame
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Title
Changes in Event-Related Potentials (ERPs)
Description
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.
Time Frame
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
Title
Changes in Quality of Life of the World Health Organization (WHOQOL-BREF)
Description
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.
Time Frame
Before tDCS treatment (initial) and after the end of the tDCS treatment (final)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ester MN Palacios, MD, PhD
Organizational Affiliation
Federal University of Espírito Santo
Official's Role
Study Director
Facility Information:
Facility Name
Federal University of Espírito Santo
City
Vitória
State/Province
ES - Espírito Santo
ZIP/Postal Code
29060-720
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23891741
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.
Results Reference
background
PubMed Identifier
24256621
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.
Results Reference
background
PubMed Identifier
25008145
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.
Results Reference
background
PubMed Identifier
30018558
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.
Results Reference
result
Learn more about this trial
Bilateral Prefrontal Modulation in Alcoholism
We'll reach out to this number within 24 hrs