Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependent Patients: a Mechanistic Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The change from baseline on the amplitude of the LPP at 8 weeks
研究概览
简要总结
The investigators hypothesize that repetitive transcranial magnetic stimulation (rTMS) on the right side of the head will make craving towards alcohol less severe in recently detoxified alcohol addicted patients.
Although there are successful treatment option to detoxify patients form their alcohol use, many patients tend to relapse. This relapse is mainly caused by a high level of (uncontrollable) craving towards alcohol. This aspect of addiction is with the existing options hard to treat, there is a great need of new successful treatment modalities. rTMS is a FDA approved treatment method for depression. Recently some small scale studies have shown promising results on rTMS in the treatment of addiction. In this study the investigators focus on alcohol addiction since it is the addiction with the highest morbidity and mortality in the Netherlands.
详细描述
In this study the investigators focus on three levels of interest: the biological level, the functional level and the clinical level. The investigators will measure the effect of rTMS directly on brain activity through EEG recording. The investigators investigate its effects on cognitive performance through the use of neuropsychological computer tasks. The investigators will address clinical behavior (craving and alcohol use) with questionnaires.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Right-handed males between 23-65 years of age
- •A primary diagnose of alcohol dependence (meeting the DSM-IV-TR criteria 303.90/ICD-10 F10.2)
- •Written consent for participation of the study.
排除标准
- •MATE outcome <4 (as extracted from part 4 MATE at enrollment phase)MATE= Dutch screening instrument on (among others) addiction severity
- •Presence of a current or past relevant somatic or neurological disorder
- •Meeting the DSM-IV-TR criteria for a current bipolar disorder, schizophrenia, anxiety disorder or moderate to severe depressive disorder. These disorders would be a possible great confounder. Measured with the MINI-plus.
- •Meeting the DSM-IV-TR criteria for current (in the past 2 weeks) dependence of substances other than alcohol, nicotine or caffeine. Information present in MATE.
- •Participant-bound factors that may endanger participants or may jeopardize study adherence, because of failure to understand and/or comply with instructions (e.g. current, disruptive symptoms such as psychotic symptoms or severe cognitive impairment)
- •Contra-indications resulting from the use of rTMS:
- •Epilepsy, convulsion or seizure
- •Serious head trauma or brain surgery
- •Large or ferromagnetic metal parts in the head (except for a dental wire)
- •Implanted cardiac pacemaker or neurostimulator
结局指标
主要结局
The change from baseline on the amplitude of the LPP at 8 weeks
时间窗: 8 weeks after start of treatment.
To investigate the effect of 20 sessions of rTMS on the change in amplitude of the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured with EEG at 8 weeks after start of treatment (baseline measurement).
次要结局
- Change from baseline on CCT at 2 weeks(at 2 weeks after start treatement)
- Change form baseline on alcohol use at 4 weeks after start treatment(at 4 weeks after start treatment)
- Change form baseline on alcohol use at 12 weeks after start treatment(at 8 weeks after start treatment)
- The change from baseline on the amplitude of the LPP at 2 weeks(2 weeks after start of treatment)
- The change from baseline on the amplitude of the LPP at 4 weeks(4 weeks after start of treatment)
- The change from baseline on the amplitude of the LPP at 12 weeks(12 weeks after start of treatment)
- The change from baseline on the amplitude of the ERN at 2 weeks(2 weeks after start of treatment)
- The change from baseline on the amplitude of the ERN at 4 weeks(4 weeks after start of treatment)
- The change from baseline on the amplitude of the ERN at 8 weeks(8 weeks after start of treatment)
- The change from baseline on the amplitude of the ERN at 12 weeks(12 weeks after start of treatment)
- Change from baseline on SST at 2 weeks(at 2 weeks after start treatement)
- Change from baseline on AAAT at 2 weeks(at 2 weeks after start treatement)
- Change from baseline on SST at 4 weeks(at 4 weeks after start treatement)
- Change from baseline on SST at 8 weeks(at 8 weeks after start treatement)
- Change from baseline on SST at 12 weeks(at 12 weeks after start treatement)
- Change from baseline on CCT at 4 weeks(at 4 weeks after start treatement)
- Change from baseline on CCT at 8 weeks(at 8 weeks after start treatement)
- Change from baseline on CCT at 12 weeks(at 12 weeks after start treatement)
- Change from baseline on AAAT at 4 weeks(at 4 weeks after start treatement)
- Change from baseline on AAAT at 8 weeks(at 8 weeks after start treatement)
- Change from baseline on AAAT at 12 weeks(at 12 weeks after start treatement)
- Change form baseline on craving at 2 weeks after start treatment(at 2 weeks after start treatment)
- Change form baseline on craving at 4 weeks after start treatment(at 4 weeks after start treatment)
- Change form baseline on craving at 8 weeks after start treatment(at 8 weeks after start treatment)
- Change form baseline on craving at 12 weeks after start treatment(at 12 weeks after start treatment)
- Change form baseline on alcohol use at 2 weeks after start treatment(at 2 weeks after start treatment)