The objective of this study is to identify clinical and non-invasive neuroimaging markers that are characteristic for RBD in PD and DLB.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Group comparisons (PD/DLB with RBD versus without RBD) and correlation analyses
with RSWA for the total sample will be performed for:
- Clinical characteristics (i.e. motor, psychiatric, autonomous and sleep
symptoms)
- Brain activity during rest, using fMRI
- Brain anatomy in terms of cortical thickness, regional volume and white
matter integrity, using structural MRI and DTI
- Iron content in the substantia nigra and basal ganglia, using quantitative MRI
- Blood and CSF protein values
Secondary outcome
Not applicable
Background summary
RBD is a condition characterized by episodes with (often violent) enactment of
dreams using movements and vocalizations. The RBD episodes take place during
REM sleep and relate to the loss of muscle atonia in this sleep stage.
Longitudinal studies on patients with RBD demonstrate that the vast majority of
them (>80%) develops a neurodegenerative disease, primarily a
synucleinopathy, such as Parkinson's disease (PD) and dementia with Lewy bodies
(DLB). The presence of RBD in these diseases is associated with a worse
prognosis related to faster cognitive decline and early development of dementia
in PD and early onset of Parkinsonism and visual hallucinations in DLB. It
remains unclear, however, why only a subset van PD/DLB patients suffers from
RBD and how this disorder contributes to the pathophysiology of synucleinopathy
and progressive neurodegeneration.
Study objective
The objective of this study is to identify clinical and non-invasive
neuroimaging markers that are characteristic for RBD in PD and DLB.
Study design
This is a cross-sectional multicenter study (VUmc, SEIN and Spinoza Centre), in
which four patient groups (PD with and without RBD and DLB with and without
RBD) will be investigated. Clinical (i.e. motor, psychiatric, autonomous and
sleep symptoms) and high resolution MRI, blood and CSF measures will be
collected.
Study burden and risks
The burden for participants for inclusion will consist of:
- Signing the informed consent during the first visit (10 min; minimal burden)
- Interview on sleep history (30 min; minimal burden)
- Fill out self-report questionnaire (20 min; minimal burden)
- Polysomnography at home (one night)
The burden for participant after meeting the inclusion criteria will consist of:
- Self-report questionnaires (60 min)
- Visiting the Spinoza Centre (clinical measures and MRI; in total ±4 hours.
In-between sessions there will be breaks. the risks with MRI are low.
De Boelelaan 1108
Amsterdam 1081 HZ
NL
De Boelelaan 1108
Amsterdam 1081 HZ
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74498.029.20 |