tDCS_ALCOHOL: Bilateral Prefrontal Modulation in Alcoholism
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Craving [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.
Other Outcome Measures
- Changes in Frontal Assessment Battery (FAB) Scores [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.
- Changes in Mini-Mental Status Examination (MMSE) [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.
- Changes in Hamilton Depression Rating Scale (HAM-D) [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.
- Changes in Hamilton Anxiety Rating Scale (HAM-A) [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.
- Changes in Event-Related Potentials (ERPs) [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.
- Changes in Quality of Life of the World Health Organization (WHOQOL-BREF) [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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federal University of Espírito Santo | Vitória | ES - Espírito Santo | Brazil | 29060-720 |
Sponsors and Collaborators
- Federal University of Espirito Santo
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Harvard Medical School (HMS and HSDM)
- University of Göttingen
Investigators
- Study Director: Ester MN Palacios, MD, PhD, Federal University of Espírito Santo
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- tDCS ALCOHOL CEP_UFES 384281
- CNPq_ 475232/2013-5
Study Results
Participant Flow
| Recruitment Details | AUD patients of both genders were successively recruited between June of 2015 and January of 2018 from three specialized clinics for drug dependence treatment, one public and two privates, from the State of Espírito Santo, Brazil. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Real tDCS | Sham-tDCS |
|---|---|---|
| Arm/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). 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. | 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. |
| Period Title: Overall Study | ||
| STARTED | 26 | 23 |
| COMPLETED | 23 | 22 |
| NOT COMPLETED | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | Real tDCS | Sham-tDCS | Total |
|---|---|---|---|
| Arm/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). 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. | 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. | Total of all reporting groups |
| Overall Participants | 23 | 22 | 45 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
46.3
(12.0)
|
43.5
(10.2)
|
44.9
(11.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
21.7%
|
3
13.6%
|
8
17.8%
|
| Male |
18
78.3%
|
19
86.4%
|
37
82.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
11
47.8%
|
12
54.5%
|
23
51.1%
|
| Brown |
8
34.8%
|
6
27.3%
|
14
31.1%
|
| Black |
4
17.4%
|
4
18.2%
|
8
17.8%
|
| Years of education (Count of Participants) | |||
| Up to 5 |
13
56.5%
|
9
40.9%
|
22
48.9%
|
| Between 6 to 9 |
1
4.3%
|
4
18.2%
|
5
11.1%
|
| Between 10 to 13 |
5
21.7%
|
5
22.7%
|
10
22.2%
|
| Above 13 |
3
13%
|
4
18.2%
|
7
15.6%
|
| Not reported |
1
4.3%
|
0
0%
|
1
2.2%
|
| Employment situation (Count of Participants) | |||
| Formal job |
2
8.7%
|
6
27.3%
|
8
17.8%
|
| Informal job |
2
8.7%
|
0
0%
|
2
4.4%
|
| Unemployed |
11
47.8%
|
10
45.5%
|
21
46.7%
|
| Freelance |
2
8.7%
|
2
9.1%
|
4
8.9%
|
| Disease benefit |
3
13%
|
0
0%
|
3
6.7%
|
| Not reported |
1
4.3%
|
2
9.1%
|
3
6.7%
|
| Retired |
2
8.7%
|
2
9.1%
|
4
8.9%
|
| Marital state (Count of Participants) | |||
| Single |
15
65.2%
|
7
31.8%
|
22
48.9%
|
| Married or common-law |
7
30.4%
|
7
31.8%
|
14
31.1%
|
| Divorced |
0
0%
|
6
27.3%
|
6
13.3%
|
| Widow |
1
4.3%
|
1
4.5%
|
2
4.4%
|
| Not reported |
0
0%
|
1
4.5%
|
1
2.2%
|
| Tobacco use (Count of Participants) | |||
| Yes |
12
52.2%
|
11
50%
|
23
51.1%
|
| No |
11
47.8%
|
11
50%
|
22
48.9%
|
| Age at onset of alcohol use (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
15.5
(5.4)
|
16.9
(6.0)
|
16.2
(5.7)
|
| Amount of alcohol used (drinks/day) (drinks/day) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [drinks/day] |
20.3
(13.4)
|
15.5
(15.0)
|
17.9
(14.3)
|
| Days of abstinence before study (days) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [days] |
33.0
(12.4)
|
32.9
(12.5)
|
33.0
(12.7)
|
Outcome Measures
| 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. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Real tDCS | Sham-tDCS |
|---|---|---|
| Arm/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). 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. | 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. |
| Measure Participants | 23 | 22 |
| Initial scores (1st week) |
5.522
(4.44)
|
3.818
(4.468)
|
| During treatment (2nd week) |
4.391
(3.751)
|
4.136
(4.549)
|
| During treatment (3rd week) |
3.348
(3.485)
|
3.545
(3.961)
|
| During treatment (4th week) |
1.739
(2.544)
|
3.273
(4.322)
|
| Final scores (5th week) |
1.565
(2.409)
|
2.455
(3.674)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Real tDCS, Sham-tDCS |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.01 |
| Comments | Two-way ANOVA with repeated measures followed by Bonferroni's multiple comparisons as post-hoc test and linear regression analyses. Additional comparisons between initial and final OCDS scores were done by paired t tests for each group. | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Real tDCS, Sham-tDCS |
|---|---|---|
| Comments | Additional comparisons between initial and final OCDS scores were done by paired t tests for each group, and differences between final and initial scores were compared between sham-tDCS and tDCS groups with unpaired t tests. | |
| Type of Statistical Test | Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.05 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Real tDCS | Sham-tDCS |
|---|---|---|
| Arm/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). | 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). |
| Measure Participants | 23 | 22 |
| initial |
12.48
(4.19)
|
11.14
(2.95)
|
| final |
13.26
(4.41)
|
13.32
(3.59)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Real tDCS | Sham-tDCS |
|---|---|---|
| Arm/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). | 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). |
| Measure Participants | 23 | 22 |
| initial |
23.13
(8.67)
|
24.91
(5.82)
|
| final |
23.87
(8.42)
|
24.64
(5.9)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Real tDCS | Sham-tDCS |
|---|---|---|
| Arm/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). | 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). |
| Measure Participants | 23 | 22 |
| initial |
2.95
(2.1)
|
3.0
(1.75)
|
| final |
2.17
(1.88)
|
2.73
(2.25)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Real tDCS | Sham-tDCS |
|---|---|---|
| Arm/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). | 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). |
| Measure Participants | 23 | 22 |
| initial |
4.26
(5.9)
|
3.77
(3.93)
|
| final |
3.87
(7.51)
|
3.91
(6.36)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ERP data was not possible in the total sample of each group because of technical difficulties. |
| Arm/Group Title | Real tDCS | Sham-tDCS |
|---|---|---|
| Arm/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). | 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). |
| Measure Participants | 10 | 8 |
| Mean (Standard Deviation) [percent change] |
-30.34
(28.68)
|
125.7
(141.6)
|
| 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) |
Outcome Measure Data
| Analysis Population Description |
|---|
| These data was not collected correctly. |
| Arm/Group Title | Real tDCS | Sham-tDCS |
|---|---|---|
| Arm/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). | 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). |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment. | |||
| Arm/Group Title | Real tDCS | Sham-tDCS | ||
| Arm/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). 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. | 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. | ||
All Cause Mortality |
||||
| Real tDCS | Sham-tDCS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/22 (0%) | ||
Serious Adverse Events |
||||
| Real tDCS | Sham-tDCS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/23 (0%) | 0/22 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Real tDCS | Sham-tDCS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/23 (69.6%) | 13/22 (59.1%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Tingling in the scalp | 16/23 (69.6%) | 16 | 13/22 (59.1%) | 13 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Ester Miyuki Nakamura-Palacios |
|---|---|
| Organization | Federal University of Espírito Santo |
| Phone | +55 27 3335-7337 |
| emnpalacios@gmail.com |
- tDCS ALCOHOL CEP_UFES 384281
- CNPq_ 475232/2013-5