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The additive effects of combined brain stimulation and behavioural training on the treatment of alcohol dependence.

Clinical Intervention with tDCS and Alcohol Avoidance Training

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28847
Enrollment
90
Registered
2014-03-17
Start date
2014-02-24
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 dependent

Interventions

1. Intervention: combined tDCS during CBM: 1 week with 4 sessions of 20 min. of 2 mA (real) tDCS during alcohol-AAT training, 1 week break, 1 week of 4 sessions of 30 s. of 2 mA (sham) tDCS during ne

Sponsors

University of Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age: 18-65; Sex: 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

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

Secondary

MeasureTime frame
These secondary outcome measurements can give us information on the possible underlying beneficial mechanisms of the training. The secondary outcome measurements are related to clinical success. The secondary measurements 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. Automatic avoidance bias towards alcohol: manipulation check (in approach/avoidance task (AAT) & transfer in 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, mean for IAT) for approach 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)). Craving is predictive of relapse. These specific measures are relevant in comparing underlying group effects, since studies using tDCS have previously repetitively found effects on craving, however effects of AAT training on craving are less strong. It could be a way of differentiating between relevant clinical mechanisms between the three different groups. The short VAS scales will give insight into direct effect of tDCS and AAT over time. Timepoints: before and after each tDCS session. PACS scores can indicate clinical relevant outcome of training overall. Timepoints: before training week 1, before training week 2, after training week 2. Phys

Contacts

Public ContactT.E. Uyl, den

Weesperplein 4

T.E.denUyl@outlook.com+31205256725

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)