The primary objective of this study is to detect statistically significant differences between the most severely affected PD subtype and controls on 3T imaging parameters.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters of this study will include clinical and magnetic
resonance imaging (MRI) parameters. Clinical data include important demographic
and disease-related characteristics as well as measures for disease severity,
and the important motor (motor functioning and motor complications) and
non-motor domains (cognition, depression, psychotic symptoms, depression, sleep
problems, and autonomic dysfunction). The combination of clinical scores
allocates patients in one of the four subtypes, and in this study, only
patients allocated in the most severe PD subtype 4 are participating. The MRI
measures will include volumetric, diffusion, and functional MRI.
Secondary outcome
Not applicable.
Background summary
The clinical heterogeneity among patients with Parkinson*s disease (PD)
reflects the existence of subtypes. Recently, four distinct subtypes which
differ with respect to the severity of a complex of predominantly
non-dopaminergic features and motor complications were identified in PD
patients with longstanding disease. At disease onset, these clinical
characteristics unfortunately are not an important feature of the phenotype and
thus are of no or limited use in predicting subtypes. Quantitative biomarkers
of the characteristics which discriminate the existing subtypes may have the
potential to identify subtypes before overt expression of the disorder. With
regard to the field of imaging, not much is known about potential biomarkers
possibly relevant in the discrimination of PD subtypes. In order to evaluate if
3 Tesla MRI can provide potential biomarkers for the discrimination of subtypes
in PD, a first step in the process of biomarker development is to evaluate if
patients within the most severely affected PD subtype significantly differ with
regard to the outcome measure of the potential biomarker from control subjects.
Study objective
The primary objective of this study is to detect statistically significant
differences between the most severely affected PD subtype and controls on 3T
imaging parameters.
Study design
The proposed study will be a cross-sectional case-control study.
Study burden and risks
PD is a progressive disorder with an unknown cause, with only symptomatic
treatment options. This study asks some effort from the patients and is not
directly helping the individual, but will provide more insight in the
usefulness of imaging in PD research. The duration of all measurements may lead
to fatigue in some patients; in such cases, rest periods will be offered. If
patients develop more severe symptoms due to the measurements as performed in
the study, the study will be adapted to the person*s wishes, or will be ended.
If necessary, the neurologist on duty will be consulted.
Anatomical scans will be examined by a physician for unexpected findings. In
case of an unexpected finding a neurologist will be consulted and the case will
be discussed. If necessary, the participant*s general practitioner (GP) will be
contacted within 3 weeks after the scan. The participant will receive notice
that the GP was contacted; the GP will inform the participant about the
findings.
Albinusdreef 2
2333 ZA Leiden
Nederland
Albinusdreef 2
2333 ZA Leiden
Nederland
Listed location countries
Age
Inclusion criteria
PD patients must fulfill the United Kingdom Parkinson*s Disease Society Brain Bank criteria for idiopathic PD.
PD patients must be allocated to subtype 4 based on their clinical scores.
A minimum age of 18 years is required for both patients and control subjects.
Exclusion criteria
Control subjects with a disease of the central nervous system.
Participants with a contraindication for MRI.
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 | NL31831.058.10 |