Extensive phenotyping of REM sleep behavior disorder in patients with Parkinson*s disease and Dementia with Lewy bodies

Recruiting

Conditions: dream sleep behavior disorder
parasomnia
10040998

Registration Number: NL-OMON54258

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Diagnosed with probable or possible DLB according to the McKeith diagnostic
criteria or diagnosed with PD according to the Movement Disorder Society
clinical diagnostic criteria for Parkinson*s disease. - Being able to read and
understand Dutch
- Being able to understand the aim of the study and the study procedure and
give written informed consent
- Absence of medication that is known to precipitate RSWA/RBD, particularly the
antidepressants venlafaxine, serotonin-specific reuptake inhibitors (SSRIs),
mirtazapine and other antidepressant agents (but not bupropion), and medication
that is known to reduce RSWA (melatonin).
- Signed statement of eligibility to participate from the treating specialist
(e.g. neurologist)

Exclusion Criteria

We will include 80 subjects in the final study; we expect that we will lose
~20% during screening due to exclusion criteria listed below, and therefore
expect to screen appr. 100 patients. All patients - A history of
neurodegenerative disorders that affect the central nervous system other than
PD or DLB - A contraindication to MRI (i.e. metal implants, cardiac pacemakers,
prior exposition to metal flakes without an X-ray showing absence of embedded
metal in the body, claustrophobia or feeling uncomfortable in small, enclosed
spaces, being pregnant) - Patients who have received brain surgery for
Parkinson*s disease - Unwillingness to be informed of unexpected medical
findings After polysomnography - Untreated moderate to severe obstructive sleep
apnea (AHI>=15/h) - None or insufficient amounts (< 5 min) of REM sleep
during polysomnography

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Group comparisons (PD/DLB with RBD versus without RBD) and correlation analyses<br /><br>with RSWA for the total sample will be performed for:<br /><br>- Clinical characteristics (i.e. motor, psychiatric, autonomous and sleep<br /><br>symptoms)<br /><br>- Brain activity during rest, using fMRI<br /><br>- Brain anatomy in terms of cortical thickness, regional volume and white<br /><br>matter integrity, using structural MRI and DTI<br /><br>- Iron content in the substantia nigra and basal ganglia, using quantitative MRI<br /><br>- Blood and CSF protein values</p><br>

Secondary Outcome Measures