Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for Reduction of Negative Affect and Treatment of Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in percent days abstinent as measured by the Time Line Follow Back
研究概览
简要总结
The objective of the current study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on self-reported negative affect, cerebellar brain activation and alcohol use outcomes in alcohol use disorder (AUD).
详细描述
To achieve study aims, 34 treatment seeking adults with AUD will be recruited from local intensive outpatient (IOP) treatment programs and randomized to treatment with either inhibitory 1Hz rTMS to cerebellar vermis given daily for 2 weeks (total of 10 sessions) or sham. Alcohol use outcomes, self-reported negative affect, and craving will be obtained at baseline, 1 day, 1 week and 6 weeks following rTMS termination. An fMRI scan during a Stroop task will be obtained at baseline and 1 day after the final rTMS session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females age 18-65 meeting DSM-V criteria for moderate or severe AUD in the past year;
- •Interested in cutting down or quitting drinking;
- •Able to provide voluntary informed consent;
- •Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and ≥4 for women) in the past 60 days;
- •Currently receiving treatment for alcohol use disorder.
排除标准
- •Severe neurological conditions (TBI/stroke/history of a seizure/dementia and other significant cognitive illnesses);
- •Other urgent medical problems, as determined by the study physician from the history and physical exam;
- •Schizophrenia, schizoaffective disorder, bipolar I disorder
- •Suicidal thoughts (intent or plan) in the last month;
- •Current moderate or severe other SUD (except nicotine or marijuana) or other drug (except nicotine or marijuana) use in the past month;
- •Active legal problems with the potential to result in incarceration;
- •Pregnancy or lactation, or child bearing age and sexually active but not on birth control (barrier methods allowed);
- •Current daily use of anti-craving medications, antidepressants (at doses considered therapeutic for depression), benzodiazepines, antipsychotics (at doses considered therapeutic for psychosis or mood stabilization), mood stabilizers (at doses considered therapeutic for mood stabilization);
- •Have previously undergone rTMS (to assure the blind is effective);
- •Personal or familial (in first degree relatives) history of epilepsy;
- •Any contraindication for Magnetic Resonance Imaging (MRI) or TMS including metal shards or certain implants (pacemakers etc.) in the body.
结局指标
主要结局
Change in percent days abstinent as measured by the Time Line Follow Back
时间窗: 3 weeks
Change in percent days abstinent as measured by the Time Line Follow Back from the 90 days prior to day 1 to day 14-21 (post-treatment).
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scales
时间窗: 2 weeks
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scale T scores from baseline to day 15 (post-treatment).
Time to drinking relapse as measured by the Time Line Follow Back
时间窗: 8 weeks
Time to drinking relapse as measured by the Time Line Follow Back from baseline in days.
Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI
时间窗: 2 weeks
Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI from baseline to day 15 (post-treatment). This will be calculated using a mask derived from preliminary data from a sample of 33 individuals with AUD at a single timepoint. Activation in this brain region was correlated with depression, anxiety, and recent drinking. Manuscript describing this result is under review (Wilcox et al.), and another manuscript describes the task in question (Wilcox et al. 2014 Cognitive Control Network Function in Alcohol Use Disorder Before and During Treatment With Lorazepam. Subst Use Misuse.
次要结局
未报告次要终点
研究者
Jon Houck
Associate Professor of Translational Neuroscience
The Mind Research Network