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ID
Source
Brief title
Health condition
Parkinson's Disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To determine early and subtle MRI changes in PD patients which distinguish them from the healthy population and to create a diagnostic tool for neurologists based on these differences.
Secondary outcome
- To detect whether different clinical phenotypes of PD patients also show different imaging characteristics.
- To correlate MRI characteristics to clinical phenotype, genetic characteristics and progression of symptoms and thereby providing a prognostic tool for individual PD patients.
Background summary
Introduction: The diagnosis of Parkinson’s Disease (PD) is currently based on the assessment of clinical symptoms and monitoring these symptoms over time. However, the early diagnosis can be challenging and it is often not immediately recognised. PD is a heterogeneous disease with great variability in motor manifestations, cognitive functions, autonomic complaints, disease course and response to therapy. The underlying aetiology of this clinical heterogeneity in PD is still not well understood and at this moment we are not able to predict the individual disease course of a patient. During the past years it has become well-established that new paradigms in MR imaging may be able to serve as a valuable method in the diagnostic work-up of PD and new biomarkers may even predict the disease course. Most of these studies however, have been performed in small patient cohorts or with low MRI field strengths.
Study design: We will perform a longitudinal observational 7T MRI study in a large PD patient cohort and age-matched healthy controls (HC). All subjects will undergo a 7T MRI scan of the brain at baseline and after 2 and 4 years. Moreover, a blood sample for genetic testing will be collected at baseline. Furthermore, motor, cognitive, psychological and autonomic functions of the PD subjects will be assessed at baseline and each follow-up moment. Based on these clinical parameters, PD patients will be subdivided into different clinical subgroups. Our aim is to include 130 PD patients and 60 HC in this study.
Objectives: To confirm early and subtle MRI changes in PD patients which distinguish them from the healthy population and to create a diagnostic tool for neurologists based on these differences. Secondary objectives are to detect whether different clinical phenotypes of PD patients also show different imaging characteristics and to correlate MRI characteristics to clinical phenotype, genetic characteristics and progression of symptoms.
Study objective
- It is possible to distinguish PD patients from HC based on a combination of ultra-high field MRI characteristics and Quantitative Susceptibility Maps (QSM).
- Different PD symptoms are caused by specific changes in different micro-circuits of the basal ganglia and related structures.
- The individual disease course of PD patients can be (partially) predicted by a combination of several different MRI characteristics.
Study design
T0: Baseline
T1: Follow-up after 2 years
T2: Follow-up after 4 years
Inclusion criteria
Participants are eligible for participation in this study if they meet the following criteria:
1) All patients have to be diagnosed with PD by a neurologist, within the last 3 years before inclusion.
2) A score of ≥ 24 on the Montreal Cognitive Assessment (MoCA) at baseline.
3) Able to read and understand Dutch.
4) 18 years of age or older.
5) Providing written informed consent.
Exclusion criteria
1) Subjects with contra-indications for a MRI scan, such as claustrophobia or subjects carrying incompatible metallic devices such as pacemakers and certain mechanical valves.
2) Advanced cognitive impairment (MoCA <24) or dementia according to the DSM V criteria at baseline.
3) Subjects with other neurodegenerative diseases.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7558 |
| Other | METC azM/UM : METC 18-027 |