The additive effects of combined brain stimulation and attentional retraining on the treatment of alcohol dependence

Clinical Intervention with tDCS and alcohol attentional retraining. Follow-up study with tDCS and ABM (FUSTA)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23514

Enrollment

100

Registered

2014-12-05

Start date

2014-11-04

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alcohol dependence alcohol verslaving

Interventions

1. 4 sessions of 20 min 2 mA tDCS (real) + real ABM training. 2. 4 sessions of 1 min 2 mA tDCS (sham) + real ABM training. 3. 4 sessions of 20 min 2 mA tDCS (real) + placebo ABM training. 4. 4 sess

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18-65, Gender: M/F

Exclusion criteria

Exclusion criteria: epilepsy, multiple sclerosis or other neurological illnesses, brain injury/infection, metal implants, pacemaker or other implanted apparatus, albino, pregnancy, skin condition.

Design outcomes

Primary

Measure	Time frame
Clinical relevant outcome Outcome name: Latency: time to relapse (more than 6 drinks), Timepoint: 3 months after treatment	—

Secondary

Measure	Time frame
These secondary outcome measurements can give us information on the possible underlying mechanisms of the training. The secondary outcome measurements are related to clinical success. They can tap into different processes related to addiction; namely implicit information processing (the manipulated variable); subjective craving (a widely used measure, however also difficult to interpret sometimes in patients); physiological response towards alcohol (an indirect way of indexing automatic neural changes towards alcohol). The measurement of executive functions and mood serve as to possibly check for previously found effects of tDCS on mood and cognition and for moderator or mediator analyses. Attentional bias towards alcohol: manipulation check (in ABM assessment & transfer in Alcohol memory task & approach avoidance associations (IAT)). Specific outcome on the same variable as the training, so we will be able to look at specific training effects. Increasing an avoidance bias has important beneficial consequences related to alcohol use. Bias score = RT differences (median score for AAT, dprime for memory, mean for IAT) for attend to alcohol versus avoid alcohol trials (relative to soda trials). Timepoints: before training, after training. Craving (craving scores on short VAS scale and craving questionnaire (PACS and AUQ )). The short VAS scale will give insight into direct effect of tDCS and ABM over time. Timepoints: before and after each tDCS session. PACS scores can indicate clinical relevant outcome of training overall. Timepoints: assessment 1 before training, assessment 2 after training. AUQ will give insight into cue-induced craving. Timepoints: At the beginning and end of assessment 1 before training, and at the beginning and end of assessment 2 after training. Physiological response. (HR, HRV, GSR). Objective measurement of basic fitness and physiological response towards alcohol compared to non-alcohol drinks. Timepoints: assessment 1 before tra	—

Measure

Time frame

These secondary outcome measurements can give us information on the possible underlying mechanisms of the training. The secondary outcome measurements are related to clinical success. They can tap into different processes related to addiction; namely implicit information processing (the manipulated variable); subjective craving (a widely used measure, however also difficult to interpret sometimes in patients); physiological response towards alcohol (an indirect way of indexing automatic neural changes towards alcohol). The measurement of executive functions and mood serve as to possibly check for previously found effects of tDCS on mood and cognition and for moderator or mediator analyses. Attentional bias towards alcohol: manipulation check (in ABM assessment & transfer in Alcohol memory task & approach avoidance associations (IAT)). Specific outcome on the same variable as the training, so we will be able to look at specific training effects. Increasing an avoidance bias has important beneficial consequences related to alcohol use. Bias score = RT differences (median score for AAT, dprime for memory, mean for IAT) for attend to alcohol versus avoid alcohol trials (relative to soda trials). Timepoints: before training, after training. Craving (craving scores on short VAS scale and craving questionnaire (PACS and AUQ )). The short VAS scale will give insight into direct effect of tDCS and ABM over time. Timepoints: before and after each tDCS session. PACS scores can indicate clinical relevant outcome of training overall. Timepoints: assessment 1 before training, assessment 2 after training. AUQ will give insight into cue-induced craving. Timepoints: At the beginning and end of assessment 1 before training, and at the beginning and end of assessment 2 after training. Physiological response. (HR, HRV, GSR). Objective measurement of basic fitness and physiological response towards alcohol compared to non-alcohol drinks. Timepoints: assessment 1 before tra

—

Contacts

Public ContactT.E. Uyl, den

Weesperplein 4

T.E.denUyl@outlook.com+31205256725

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)