The primary objective is to determine the diagnostic accuracy of the automated diagnostic software (mPDia, Heuron) using SMWI to distinguish neurodegenerative parkinsonism from patients with non-neurodegenerative parkinsonism compared with the final…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic accuracy of the automated diagnostic software (mPDia, Heuron)
using SMWI, compared with the final diagnosis of the neurologist.
Secondary outcome
- Contrast ratio and size of the SN and LC on nmMRI
- Iron content of SN and basal ganglia on SWI using QSM
- T1 and T2 relaxation in different brain regions using MR STAT
- Free-water present in the SN on DTI
- Architecture of white matter tracts on DTI
- Contrast ratio and size of the SN on nmSMWI
- Hoehn & Yahr stage
- MDS UPDRS that consists of the following four parts will be filmed:
I. Non-motor experiences of daily living (6 items)
II. Motor experiences of daily living (20 items)
III. Motor examination (33 items)
IV. Motor complications (6 items)
- Red flags on the MDS criteria for the diagnosis of PD3
- Montreal cognitive assessment (MoCA)
- REM sleeping behavior disorder screening
- Non-motor symptom assessment scale
- Beck Depression inventory (BDI)
- Environmental factors
- Sebum swap
Background summary
The pathophysiology of Parkinson*s disease (PD) is characterized by an
extensive and progressive loss of dopaminergic neurons of the substantia nigra
(SN). Usually, it can be well diagnosed based on its clinical symptoms.
However, particularly in the early stages of the disease, not all symptoms
might be present and the diagnosis remains challenging. Recently, novel MRI
sequences have been developed to assess the SN. More specific, susceptibility
map weighted image (SMWI) is capable of visualizing nigrosome 1 and iron
deposition in the SN. These measures are altered in nigrostriatal
neurodegeneration and therefore have the potential to benefit the diagnostic
process in parkinsonian patients in which the diagnosis remains unclear.
Recently, an automated diagnostic algorithm that utilizes this MRI sequence
showed a high potential to support the diagnosis of Parkinson*s disease within
a small group of patients with a clear clinical diagnosis. It is clinically
relevant yet unclear, how this technique performs in patients with an uncertain
clinical diagnosis.
In recent years more promising diagnostic techniques for neurodegenerative
parkinsonism have been developed. MRI sequences such as neuromelanin sensitive
MRI (nmMRI), quantitative susceptibility mapping (QSM), diffusion tensor
imaging (DTI) and MR STAT are capable to assess differences in the SN between
patients with PD and healthy controls. In addition, recent research has shown a
difference in composition of sebum in patients with PD compared with healthy
controls. However, these novel techniques are not yet applied in medical
practice and diagnostic accuracy has to been further investigated.
Study objective
The primary objective is to determine the diagnostic accuracy of the automated
diagnostic software (mPDia, Heuron) using SMWI to distinguish neurodegenerative
parkinsonism from patients with non-neurodegenerative parkinsonism compared
with the final diagnosis of a neurologist including the results of DAT SPECT
imaging. Secondary objectives are more exploratory to investigate the
diagnostic characteristics and accuracy of nmMRI, QSM, MR STAT, DTI, and
composition of sebum for neurodegenerative parkinsonism.
Study design
Combined retrospective and prospective diagnostic study.
Study burden and risks
The study does not provide a direct benefit for the participants. However, the
aim of this study is to assess the diagnostic accuracy of MRI for patients with
CUPS. MRI does not expose patients to radiation and is more widely available.
Hence, this study benefit patients with CUPS as a group. There is no known risk
of harm of the procedures of this study. Therefore, disadvantage of
participation is limited.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age above 18
- DAT-SPECT scan between January 2019 and December 2021 for clinical uncertain
parkisonian
syndrom
Exclusion criteria
- Indication for the DAT-SPECT other than CUPS
- Inability to provide informed consent
- Aboslute contra indication for MRI
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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 | NL79240.018.22 |