Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:

Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557815
• Other study ID #: EA1027
• Secondary ID: 91713354EA1027
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2015
• Last updated: September 22, 2015
• Start date: February 2012

Study information

• Verified date: September 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

References & Publications (2)

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. R — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	No
Secondary	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)	No