Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

September 22, 2015 updated by: Anneke E. Goudriaan, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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 experienced emotion from baseline, and after the stimulation session (approximately two weeks later)
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]
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anneke E Goudriaan, Prof dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

September 6, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • EA1027 (Other Grant/Funding Number: The European Foundation for Alcohol Research (ERAB))
  • 91713354 (Other Grant/Funding Number: Dutch Scientific Foundation (ZonMw))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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