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

Follow-up of [18F]fluorodeoxyglucose positron emission tomography (FDG-PET) imaging in idiopathic rapid eye movement sleep behavior disorder (iRBD)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON27392
Enrollment
100
Registered
2019-09-30
Start date
2018-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic Rapid Eye Movement Sleep Behavior Disorder (iRBD), Parkinson's Disease (PD), Dementia with Lewy Bodies (DLB), Multiple System Atrophy (MSA)

Interventions

None listed

Sponsors

Stichting Parkinsonfonds Nederland + Parkinsonfonds Deutschland
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Increase in absolute PDRP score saying something about disease state / progression

Secondary

MeasureTime frame
Increase in PDRP score over time saying something about disease state / progression

Contacts

Public ContactRosalie Vered Kogan

Universitair Medisch Centrum Groningen (UMCG)

r.v.kogan@umcg.nl+31503613541

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)