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临床试验/NCT02910193
NCT02910193已完成不适用

Alcohol Addiction: A Systems-oriented Approach; Functional Validation II: Neuroimaging x Genetics

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2016年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
1
主要终点
Functional brain imaging assessed using a Siemens Magnetom TimTrio, 3 Tesla

研究概览

简要总结

The goal of the multicenter subproject (SP) 10 of the eMED Alcohol Addiction Consortium - A Systems-Oriented Approach is to study neuroimaging x genetics predictions in an existing sample (NGFNplus) of tightly endophenotyped and genome-wide genotyped alcohol dependent subjects (N=240) and controls (N=240); (ii) to translate the results of neuroimaging and genetic analyses from an adolescent risk sample (IMAGEN) to adult disease (NGFNplus sample) by examining related MRI-paradigms tagging the same functional brain systems in both samples (e.g. reward system, inhibitory control system, emotion processing, working memory); (iii) to conduct a follow-up neuroimaging study on the NGFNplus sample validating the neurobehavioral risk profiles predictive for juvenile harmful alcohol use in adult patients with alcohol addiction, (iv) to expand the NGFNplus sample by including a new set of healthy subjects with high genetic risk (1st degree relatives of patients with alcohol addiction). The investigators will do so by using elaborate imaging genetic methods that are already available and successfully used in other multicenter studies by the investigator's research group (e.g. univariate analyses, functional and effective connectivity analyses, polygenetic scores, network topology) as well as by using complex computational algorithms and mathematical models, in particular advanced machine learning methods, developed in SP 6. The investigator's approach aims in the long to predict and characterize longitudinal outcomes in patients with alcohol addiction (5 years following our index session) and to complement the NGFN-sample with an add-on study with 1st degree relatives that will allow the investigators to test the generalizability of the identified predictive risk profiles for early risk identification.

详细描述

The overall research goal of this project is (i) to study neuroimaging x genetics predictions in an existing sample (NGFNplus) of tightly endophenotyped and genome-wide genotyped alcohol dependent subjects (N=240) and controls (N=240); (ii) to translate the results of neuroimaging x genetic analyses from an adolescent risk sample (IMAGEN) to adult disease (NGFNplus sample) by examining related paradigms tagging the same functional systems in both samples; (iii) to conduct a follow-up neuroimaging study on the NGFNplus sample validating the neurobehavioral risk profiles predictive for harmful alcohol use in adolescents in adult patients with alcohol addiction (iv) to expand the NGFNplus sample by including a new set of healthy subjects with high genetic risk (1st degree relatives of patients with alcohol addiction). The investigators will do so by using imaging genetic methods that are already available and used in other multicenter studies by the investigator's research group (e.g. univariate analyses, functional and effective connectivity analyses, polygenetic scores, network topology) as well as by using computational algorithms and mathematical models, in particular advanced machine learning methods, developed in other sub projects (SPs) of the consortium in particular of SP4 and SP6. The investigator's approach will enable the researchers to characterize outcome longitudinal in patients with alcohol addiction (5 years following our index session) and to complement the NGFN-sample with an add-on study with 1st degree relatives that will allow the investigators to test the generalizability of the identified predictive risk profiles for early risk identification.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • written informed consent
  • right handedness
  • no psychiatric disorders according to the International Classification of Diseases, Version 10 (ICD-10) (in patients: other than nicotine and alcohol dependence)
  • no use of psychotropic substances during previous 3 months

排除标准

  • severe illnesses (e.g. neurological diseases)
  • MR-contraindications (e.g. pacemaker, metal or electronic implants, metal splinters)
  • no psychiatric axis I-disorders according to the International Classification of Diseases, Version 10 (ICD-10) (in patients: other than nicotine and alcohol dependence)
  • no use of psychotropic substances during previous 3 months
  • insufficient language knowledge
  • claustrophobia
  • pregnancy in women

结局指标

主要结局

Functional brain imaging assessed using a Siemens Magnetom TimTrio, 3 Tesla

时间窗: 3 year

The primary outcome measure "Blood Oxygenation Level-Dependent (BOLD) response" will be assessed as a marker of neural activation via functional brain imaging (fMRI) during the processing of emotional, monetary and alcohol-associated cues as well as cognitive demand and at rest. A Siemens Magnetom TimTrio, 3 Tesla will be used.

Structural brain imaging assessed using a Siemens Magnetom TimTrio, 3 Tesla

时间窗: 3 year

The second primary outcome measure "brain tissue (Grey Matter, White Matter, Cerebrospinal fluid)" will be assessed and quantified via structural brain imaging using magnet resonance tomography as well as defusion-tensor imaging (MRI, DTI). A Siemens Magnetom TimTrio, 3 Tesla will be used.

次要结局

  • Assessment of genetic candidate markers and epigenetic markers of alcohol use disorders(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Heinz

Prof., MD, PhD

Charite University, Berlin, Germany

研究点 (1)

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