NL-OMON46119已完成不适用
Follow-up of FDG PET imaging in idiopathic REM Sleep Behavior Disorder (RBD) - REMPET2
Rijksuniversiteit Groningen0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Age between 40 and 70 years
- •As stated in paragraph 4.1 (Population) the mean age of onset of RBD is in the 5th to 6th decade (16). Because of a mean interval of 6 * 7 years between the onset of RBD and the diagnosis of RBD (11,12), the age limit is set between age 40 and 70 years. Above the age of 70 years, the risk of comorbidity is higher.
- •- Women, only if they are postmenopausal (> 1 year no menses)
- •The effect of the FDG tracer used in an FDG PET scan on a foetus is not well known. For this reason, women can only participate if they are postmenopausal, even though the risk of a woman being pregnant in the age limit used in this study is low. Also, RBD is more frequent in men (80 * 82 percent) as compared to women (8,17).
- •- Written informed consent
- •- Capacity to understand the study;Diagnosis of RBD according to the criteria of International Classification of Sleep Disorders (ASDA Criteria 2005): (18);- The subject has a complaint of violent or injurious behavior during sleep.
- •- Limb or body movement is associated with dream mentation.
- •- At least one of the following occurs:
- •Harmful or potentially harmful sleep behaviors
- •Dreams appear to be *acted out*
- •Sleep behaviors disrupt sleep continuity
- •- Video-polysomnographic (PSG) monitoring demonstrates at least one of the following electrophysiologic measures during REM sleep:
- •Excessive augmentation of chin electromyography (EMG) tone
- •Excessive chin or limb phasic EMG twitching, irrespective of chin EMG
- •activity and one or more of the following clinical features during REM sleep: excessive limb or body jerking; complex, vigorous, or violent behaviors; absence of epileptic activity in association with the disorder
- •- The symptoms are not associated with mental disorders, but may be associated with neurologic disorders.
- •- Other sleep disorders (e.g., sleep terrors or sleepwalking) can be present, but are not the cause of the behavior.
- •- REMPET1 subjects who have phenoconverted to PD/DLB/MSA will be excluded from REMPET2.
排除标准
- •* Claustrophobia
- •* For the MRI scan further contraindications are given.
- •* Abuse of drugs or alcohol at present or in the past as determined by disclosed medical history
- •* Kidney diseases with elevated levels of blood creatinine, liver diseases with elevated levels of blood transaminases (at least 3 times as high than normal), or an elevated blood level of gamma-GT (at least 5 times higher than normal)
- •* Hyperglycaemia before the FDG PET scan (> 7 mmol/l)
- •* Use of benzodiazepines during the day before FDG PET scan
- •* Structural cerebral lesion or any other neurological disease which can interfere with the analysis of the image data (for example, a stroke in the past)
- •* Diagnosis of any parkinsonism or dementia
- •* If subjects do not want to be informed about an unforeseen clinical finding
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