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Published in: BMC Psychiatry 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: Renée S. Schluter, Ruth J. van Holst, Anna E. Goudriaan

Published in: BMC Psychiatry | Issue 1/2018

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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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Metadata
Title
Repetitive transcranial magnetic stimulation (rTMS) in alcohol dependence: study protocol of a randomized controlled clinical trial of efficacy and working mechanisms
Authors
Renée S. Schluter
Ruth J. van Holst
Anna E. Goudriaan
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2018
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-018-1759-y

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