EUCTR2013-004244-37-GB进行中（未招募）1 期
The control of brain networks after traumatic brain injury: a neuroimaging and neuropsychological study of dopamine and cognition - Dopamine dysregulation following TBI
Imperial College London | Imperial College NHS Healthcare Trust0 个研究点开始时间: 2013年12月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion criteria (TBI patients):
- •a diagnosis of traumatic brain injury (TBI) at least 3 months prior to recruitment into the study
- •age between 20 and 65 years
- •right-handed
- •capable of giving written informed consent
- •the presence of cognitive impairment as assessed on tests of information processing speed, working memory and attention tasks
- •Inclusion criteria (controls):
- •age between 20 and 65 years and in good general health (defined as no clinically relevant abnormalities identified on detailed medical history, physical examination, including blood pressure and pulse rate, and clinical laboratory tests)
- •right-handed
- •capable of giving written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion criteria (TBI patients):
- •unwillingness or inability to follow the procedures required
- •significant neurological or psychiatric illness diagnosed prior to the TBI
- •family history of a first degree relative with a psychotic illness
- •currently participating in a clinical trial or has done so within 1 month before screening
- •use of any medication or substance that, in the opinion of the investigators, would interfere with the study or compromise participant safety
- •history of a drug or other allergy that, in the opinion of the investigators, contraindicates their participation in the study
- •history of current or past drug or alcohol addiction
- •female participants who are breast feeding or pregnant (positive pregnancy test) or plan to become pregnant during the study
- •positive urine drug screen
- •contraindication to MRI scanning, assessed by a standard pre-MRI questionnaire
- •contraindication to the use of methylphenidate (including medications deemed to have a potentially serious interaction with methylphenidate as per the British National Formulary)
- •clinical evidence of motor symptoms of Parkinsonism as assessed by a Neurologist
- •Exclusion criteria (controls):
- •unwillingness or inability to follow the procedures required
- •significant current or previously diagnosed neurological or psychiatric illness
- •family history of a first degree relative with a psychotic illness
- •currently participating in a clinical trial or has done so within 1 month before screening
- •use of any medication or substance that, in the opinion of the investigators, would interfere with the study or compromise participant safety
- •history of a drug or other allergy that, in the opinion of the investigators, contraindicates their participation in the study
- •history of current or past drug or alcohol addiction
- •female participants who are breast feeding or pregnant (positive pregnancy test) or plan to become pregnant during the study
- •positive urine drug screen
- •contraindication to MRI scanning, assessed by a standard pre-MRI questionnaire
研究者
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