NCT02557815

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

September 6, 2015

Last Update Submit

September 22, 2015

Conditions

Alcohol Dependence

Keywords

Repetitive Transcranial Magnetic StimulationEmotion RegulationCraving

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • 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)

Study Arms (2)

Active Repetitive Transcranial Magnetic Stimulation (rTMS)

EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation: Active 10hz stimulation over the right dorsolateral Prefrontal Cortex (dlPFC)

Device: Repetitive Transcranial Magnetic Stimulation

Sham stimulation

SHAM COMPARATOR

Repetitive Transcranial Magnetic Stimulation: sham stimulation over the right dlPFC

Device: Repetitive Transcranial Magnetic Stimulation

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus

Active Repetitive Transcranial Magnetic Stimulation (rTMS)Sham stimulation

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Alcohol Dependence
  • Currently abstinent

You may not qualify if:

  • psychoactive medication
  • not eligible for MRI (metals or claustrophobia)
  • (familial) history of epilepsy
  • current psychiatric disorders (besides alcohol dependence)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Jansen JM, van Holst RJ, van den Brink W, Veltman DJ, Caan MW, Goudriaan AE. Brain function during cognitive flexibility and white matter integrity in alcohol-dependent patients, problematic drinkers and healthy controls. Addict Biol. 2015 Sep;20(5):979-89. doi: 10.1111/adb.12199. Epub 2014 Dec 5.

    PMID: 25477246BACKGROUND

  • Jansen JM, Daams JG, Koeter MW, Veltman DJ, van den Brink W, Goudriaan AE. Effects of non-invasive neurostimulation on craving: a meta-analysis. Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2472-80. doi: 10.1016/j.neubiorev.2013.07.009. Epub 2013 Jul 31.

    PMID: 23916527RESULT

  • Jansen JM, van den Heuvel OA, van der Werf YD, de Wit SJ, Veltman DJ, van den Brink W, Goudriaan AE. The Effect of High-Frequency Repetitive Transcranial Magnetic Stimulation on Emotion Processing, Reappraisal, and Craving in Alcohol Use Disorder Patients and Healthy Controls: A Functional Magnetic Resonance Imaging Study. Front Psychiatry. 2019 May 7;10:272. doi: 10.3389/fpsyt.2019.00272. eCollection 2019.

    PMID: 31133889DERIVED

  • Jansen JM, van den Heuvel OA, van der Werf YD, de Wit SJ, Veltman DJ, van den Brink W, Goudriaan AE. Emotion Processing, Reappraisal, and Craving in Alcohol Dependence: A Functional Magnetic Resonance Imaging Study. Front Psychiatry. 2019 Apr 9;10:227. doi: 10.3389/fpsyt.2019.00227. eCollection 2019.

    PMID: 31057439DERIVED

MeSH Terms

Conditions

AlcoholismEmotional Regulation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Anneke E Goudriaan, Prof dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

September 6, 2015

First Posted

September 23, 2015

Study Start

February 1, 2012

Primary Completion

October 1, 2014

Last Updated

September 23, 2015

Record last verified: 2015-09