Changing the Vulnerable Brain: A Neuromodulation Study in Alcohol Dependence

NCT ID: NCT02557815

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Brief Summary

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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

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Conditions

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Alcohol Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Active Repetitive Transcranial Magnetic Stimulation (rTMS)

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

Group Type EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus

Sham stimulation

Repetitive Transcranial Magnetic Stimulation: sham stimulation over the right dlPFC

Group Type SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus

Interventions

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Repetitive Transcranial Magnetic Stimulation

Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Anneke E. Goudriaan

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anneke E Goudriaan, Prof dr.

Role: PRINCIPAL_INVESTIGATOR

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

References

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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.

Reference Type BACKGROUND
PMID: 25477246 (View on PubMed)

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.

Reference Type RESULT
PMID: 23916527 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31133889 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31057439 (View on PubMed)

Other Identifiers

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91713354

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EA1027

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EA1027

Identifier Type: -

Identifier Source: org_study_id

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