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Longitudinal ultra-high field imaging in Parkinson*s Disease: Tracking the disease course

Longitudinal ultra-high field imaging in Parkinson*s Disease: Tracking the disease course - TRACK-PD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54720
Enrollment
190
Registered
2018-12-20
Start date
2019-07-02
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Parkinson's disease

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for Parkinson's disease patients: -18 years of age or older. -Recently diagnosed idiopathic Parkinson's Disease according to the UK Brain Bank Criteria (

Exclusion criteria

Exclusion criteria: Exclusion criteria for all subjects: -Subjects with contra-indications for a MRI scan as defined in the MRI screenings form of Scannexus (Appendix E), such as claustrophobia or subjects carrying incompatible metallic devices such as pacemakers and certain mechanical valves. -Advanced cognitive impairment (MoCA

Design outcomes

Primary

MeasureTime frame
The main study endpoint will be the structural and functional changes of the PD brain as compared to HC, which will be assessed on 7T ultra-high field MR images. We will also use quantitative MRI approaches, since this enables us to detect small structural and anatomical differences which cannot be detected on qualitative MRI acquisitions. Our aim is to create a diagnostic tool, based on MRI characteristics, which can distinguish PD patients from HC.

Secondary

MeasureTime frame
A secondary study endpoint will be the detection of differences in imaging characteristics between clinically dissimilar subtypes of PD. We aim to correlate clinical phenotype, genetic characteristics and progression of symptoms to functional and structural MRI variations. This requires a longitudinal follow-up, which enables us to establish in what manner progression of clinical symptoms is related to certain neuroimaging characteristics. Furthermore, our aim is to develop a patient specific prognostic model based on MRI characteristics, which can (partially) predict the disease course for the individual patient. Moreover, we aim to assess the potential of brain-enriched EV miRNAs in blood to distinguish PD from the healthy population.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)