Repetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanisms

Abstract Background High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has gained interest as a neuromodulation treatment technique for alcohol dependence. Single sessions of HF-rTMS have consistently shown to decrease craving for substances. However, the results of randomized con...

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Main Authors: Renée S. Schluter, Ruth J. van Holst, Anna E. Goudriaan
Format: Article
Language:English
Published: BMC 2018-06-01
Series:BMC Psychiatry
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12888-018-1759-y
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author Renée S. Schluter
Ruth J. van Holst
Anna E. Goudriaan
author_facet Renée S. Schluter
Ruth J. van Holst
Anna E. Goudriaan
author_sort Renée S. Schluter
collection DOAJ
description Abstract Background High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has gained interest as a neuromodulation treatment technique for alcohol dependence. Single sessions of HF-rTMS have consistently shown to decrease craving for substances. However, the results of randomized controlled clinical trials investigating the effect of multiple HF-rTMS sessions in alcohol dependence on abstinence rates and craving are inconsistent. Furthermore, they lack information on the effect of HF-rTMS on cognition and brain functioning. Methods A single center, single blind, randomized controlled trial with 80 abstinent alcohol dependent subjects in treatment randomized (1:1) to either treatment as usual (TAU) plus ten sessions of active HF-rTMS or TAU plus 10 sessions of placebo/ sham HF-rTMS will be performed. The effects of ten HF-rTMS sessions on craving and neurocognitive functions are obtained. In addition a subset of participants will undergo an MR scanning session before the first and after the last HF-rTMS session in order to investigate the effect of ten HF-rTMS sessions on brain functioning. The primary outcome is the continued abstinence rate after the add-on HF-rTMS treatment. Discussion This study uses a randomized controlled trial to examine the clinical, neurocognitive and brain functioning effects of ten add-on HF-rTMS sessions in alcohol dependent individuals in treatment. If the add-on treatment is effective, this may add to the evidence needed for approval of this additional treatment method for alcohol dependence by regulatory authorities. Trial registration The Netherlands National Trial Register (NTR), NTR5291, 6-July-2015.
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spelling doaj.art-c7ee26c3351b4f21bf6d205dde7552072022-12-22T03:00:41ZengBMCBMC Psychiatry1471-244X2018-06-0118111210.1186/s12888-018-1759-yRepetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanismsRenée S. Schluter0Ruth J. van Holst1Anna E. Goudriaan2Department of Psychiatry and Amsterdam Institute for Addiction Research, Academic Medical Center, University of AmsterdamDepartment of Psychiatry and Amsterdam Institute for Addiction Research, Academic Medical Center, University of AmsterdamDepartment of Psychiatry and Amsterdam Institute for Addiction Research, Academic Medical Center, University of AmsterdamAbstract Background High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has gained interest as a neuromodulation treatment technique for alcohol dependence. Single sessions of HF-rTMS have consistently shown to decrease craving for substances. However, the results of randomized controlled clinical trials investigating the effect of multiple HF-rTMS sessions in alcohol dependence on abstinence rates and craving are inconsistent. Furthermore, they lack information on the effect of HF-rTMS on cognition and brain functioning. Methods A single center, single blind, randomized controlled trial with 80 abstinent alcohol dependent subjects in treatment randomized (1:1) to either treatment as usual (TAU) plus ten sessions of active HF-rTMS or TAU plus 10 sessions of placebo/ sham HF-rTMS will be performed. The effects of ten HF-rTMS sessions on craving and neurocognitive functions are obtained. In addition a subset of participants will undergo an MR scanning session before the first and after the last HF-rTMS session in order to investigate the effect of ten HF-rTMS sessions on brain functioning. The primary outcome is the continued abstinence rate after the add-on HF-rTMS treatment. Discussion This study uses a randomized controlled trial to examine the clinical, neurocognitive and brain functioning effects of ten add-on HF-rTMS sessions in alcohol dependent individuals in treatment. If the add-on treatment is effective, this may add to the evidence needed for approval of this additional treatment method for alcohol dependence by regulatory authorities. Trial registration The Netherlands National Trial Register (NTR), NTR5291, 6-July-2015.http://link.springer.com/article/10.1186/s12888-018-1759-yAlcohol dependenceHF-rTMSAbstinenceCravingNeurocognitiveNeurobiological
spellingShingle Renée S. Schluter
Ruth J. van Holst
Anna E. Goudriaan
Repetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanisms
BMC Psychiatry
Alcohol dependence
HF-rTMS
Abstinence
Craving
Neurocognitive
Neurobiological
title Repetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanisms
title_full Repetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanisms
title_fullStr Repetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanisms
title_full_unstemmed Repetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanisms
title_short Repetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanisms
title_sort repetitive transcranial magnetic stimulation rtms in alcohol dependence study protocol of a randomized controlled clinical trial of efficacy and working mechanisms
topic Alcohol dependence
HF-rTMS
Abstinence
Craving
Neurocognitive
Neurobiological
url http://link.springer.com/article/10.1186/s12888-018-1759-y
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