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Follow-up of FDG-PET imaging in idiopathic REM Sleep Behavior Disorder (RBD)

Recruiting
Conditions
idiopathic Rapid Eye Movement Sleep Behavior Disorder (iRBD), Parkinson's Disease (PD), Dementia with Lewy Bodies (DLB), Multiple System Atrophy (MSA)
Registration Number
NL-OMON27392
Lead Sponsor
Stichting Parkinsonfonds Nederland + Parkinsonfonds Deutschland
Brief Summary

from REMPET1: www.doi.org/10.1002/mds.27094, www.doi.org/10.2967/jnumed.117.202242 (First REMPET2 manuscript currently in progress)

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
100
Inclusion Criteria

Age between 40 and 80 years old
-(For women) postmenopausal (> 1 year no menses)
-Intellectual capacity to understand the study
-Diagnosis of RBD according to the criteria of International Classification of Sleep Disorders (ASDA Criteria 2005): 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 electrophysiological 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 neurological disorders. Other sleep disorders (e.g., sleep terrors or sleepwalking) can be present, but are not the cause of the behavior.

Exclusion Criteria

-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)
-Hyperglycemia before the FDG PET scan (> 7 mmol/l)
-Use of benzodiazepines during the day before the 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 before baseline FDG-PET imaging
-If subjects do not want to be informed about an unforeseen clinical finding

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Increase in absolute PDRP score saying something about disease state / progression
Secondary Outcome Measures
NameTimeMethod
Increase in PDRP score over time saying something about disease state / progression
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