Department of Psychiatry and Amsterdam Institute for Addiction Research, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Donders Institute for Cognition, Brain and Behaviour, Radboud University, Kapittelweg 29, 6525 EN, Nijmegen, Gelderland, The Netherlands.
BMC Psychiatry. 2018 Jun 4;18(1):169. doi: 10.1186/s12888-018-1759-y.
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.
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.
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.
The Netherlands National Trial Register (NTR), NTR5291 , 6-July-2015.
高频重复经颅磁刺激（HF-rTMS）作为一种神经调节治疗技术，已引起人们对治疗酒精依赖的兴趣。单次 HF-rTMS 治疗已一致显示可降低对物质的渴望。然而，调查多次 HF-rTMS 治疗对酒精依赖的戒断率和渴望影响的随机对照临床试验的结果并不一致。此外，它们缺乏关于 HF-rTMS 对认知和大脑功能影响的信息。
一项单中心、单盲、随机对照试验，纳入 80 名处于治疗中的酒精依赖的戒酒受试者，随机（1:1）分为治疗组（接受常规治疗加 10 次主动 HF-rTMS）或对照组（接受常规治疗加 10 次假/ sham HF-rTMS）。将获得 10 次 HF-rTMS 治疗对渴望和神经认知功能的影响。此外，一部分参与者将在第一次和最后一次 HF-rTMS 治疗前和治疗后进行磁共振扫描，以研究 10 次 HF-rTMS 治疗对大脑功能的影响。主要结局是附加 HF-rTMS 治疗后的持续戒酒率。
本研究使用随机对照试验来检查附加的 10 次 HF-rTMS 治疗对治疗中的酒精依赖个体的临床、神经认知和大脑功能的影响。如果附加治疗有效，这可能会增加监管机构批准这种额外的酒精依赖治疗方法所需的证据。
荷兰国家试验注册处（NTR），NTR5291，2015 年 7 月 6 日。
