Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Emotional Regulation Mental Disorders Self-Control Social Behavior Substance-Related Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus

Primary outcomes

Change in BOLD response during an emotion regulation task (fMRI)

Time frame: Change in BOLD response from baseline, compared to BOLD response after stimulation (approximately two weeks later)

BOLD response was measured during an emotion regulation task. The change in BOLD response between sessions is the primary outcome for this study

Secondary outcomes

Change in experienced emotion during an emotion regulation task with Visual Analogue Scales (VAS)

Time frame: Change in experienced emotion from baseline, and after the stimulation session (approximately two weeks later)

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 craving levels [Alcohol Urge Questionnaire (AUQ)]

Time frame: 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)

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]

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
First posted: Sep 23, 2015
Registry last updated: Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed