Sleep disorder REM-Sleep-Behavior Disorder (RBD)
Conditions
Interventions
FDG-PET
Parkinson's
PDRP
Sponsors
Rijksuniversiteit Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
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) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study Parameters / Endpoints 1) The key parameter in this study is the calculation of PDRP expression (i.e. subject scores) in the FDG-PET data images. 2) The clinical phenoconversion of the included subjects within the study time in relation to the degree of PDRP pattern: probability determination. 3) DAT-SPECT scans to determine the nigrostriatal dopaminergic status of the subjects. 4) Olfactory scores as an indication of hyposmia * hyposmia at baseline is also associated with a risk of conversion 5) MRI scans to rule out other diseases and to be able to correct for brain atrophy. | — |
Countries
The Netherlands
Outcome results
None listed