Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

Phase 3

Completed

• Conditions: Alcohol Dependence
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT02557815
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-10
• Status Verified: 2015-09
• Study First Submitted: 2015-09-06
• Study First Submitted QC: 2015-09-22
• Last Update Submitted: 2015-09-22
• Study First Posted: 2015-09-23
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Repetitive Transcranial Magnetic Stimulation	Repetitive Transcranial Magnetic Stimulation: sham stimulation over the right dlPFC
Active Repetitive Transcranial Magnetic Stimulation (rTMS)	Repetitive Transcranial Magnetic Stimulation	Repetitive Transcranial Magnetic Stimulation: Active 10hz stimulation over the right dorsolateral Prefrontal Cortex (dlPFC)

Primary Outcome Measures

Name	Time	Method
Change in BOLD response during an emotion regulation task (fMRI)	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 Outcome Measures

Name	Time	Method
Change in experienced emotion during an emotion regulation task with Visual Analogue Scales (VAS)	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)]	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 \[0 = Strongly disagree, 6 = Strongly Agree\]