Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

Study Overview
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Brief Summary
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This current project investigates the effect of a single session of right dlPFC repetitive transcranial magnetic stimulation on emotion regulation abilities and craving in alcohol dependent patients and healthy controls.

Official Title
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Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

Conditions
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Alcohol Dependence

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alcohol Dependence Currently abstinent Exclusion Criteria: psychoactive medication not eligible for MRI (metals or claustrophobia) (familial) history of epilepsy current psychiatric disorders (besides alcohol dependence)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Repetitive Transcranial Magnetic Stimulation (rTMS)<br>Repetitive Transcranial Magnetic Stimulation: Active 10hz stimulation over the right dorsolateral Prefrontal Cortex (dlPFC) | Device: Repetitive Transcranial Magnetic Stimulation<br>* Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus<br>|
| Sham Comparator: Sham stimulation<br>Repetitive Transcranial Magnetic Stimulation: sham stimulation over the right dlPFC | Device: Repetitive Transcranial Magnetic Stimulation<br>* Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BOLD response during an emotion regulation task (fMRI) | BOLD response was measured during an emotion regulation task. The change in BOLD response between sessions is the primary outcome for this study | Change in BOLD response from baseline, compared to BOLD response after stimulation (approximately two weeks later) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in experienced emotion during an emotion regulation task with Visual Analogue Scales (VAS) | Participants were instructed to either 'attend' or 'regulate' their emotion associated with the presented (negatively valenced) pictures. Experienced (or regulated) emotion was assessed with visual analogue scales (VAS). | Change in experienced emotion from baseline, and after the stimulation session (approximately two weeks later) | 
| Change in craving levels [Alcohol Urge Questionnaire (AUQ)] | The AUQ was administered in order to assess craving levels. The AUQ consists of eight statements wich are rated on a 7 point likert scale [0 = Strongly disagree, 6 = Strongly Agree] | Before and after the emotion regulation task, during both baseline and stimulation session (e.g. 4 time points, sessions were separated by approximately two weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Repetitive Transcranial Magnetic Stimulation, Emotion Regulation, Craving