Primary Objective: To investigate whether a quantitative MRI protocol can detect the difference between atypical parkinsonism and patients with Parkinson*s disease, in an early phase of the diseases when the clinical diagnosis for either is not yet…
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- Central nervous system infections and inflammations
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Outcome measures
Primary outcome
The differentiations will be made based on the following measurements:
- Atrophy measurements will be made on a sagittal view of the T1-weighted
images, without additional post-processing. This is done by measuring the
surface and diameters of the midbrain, pons and superior and middle cerebral
peduncle (8,9) for all the differentiations, and in addition for
differentiating MSA-C from the rest can be improved by looking for a
Hot-Cross-Bun Sign (HCBS) on a T2-weighted image in the pons (14,15).
- MT-weighted measurements are made in the Substantia Nigra and Locus Coeruleus
- Quantitative Susceptibility Mapping (QSM) will be done in the brain,
including the basal ganglia (putamen and globus pallidus) (6,11) and the
midbrain (nucleus ruber and substantia nigra) using, for example, the MEDI
toolbox (16).
- Diffusion MRI measures, including Fractional Anisotropy (FA) and Apparent
Diffusion Coefficient (ADC) will be conducted in the brain, including the
putamen, cerebellum and brainstem (12,17-20). This can, for example, be done
using MRtrix (21).
- Neurological examination including a UPDRS score (movement disorder severity)
and MOCA score (Cognitive test).
- Neurofilament quantification from a blood sample.
Secondary outcome
The same approaches as primary parameters will be applied, however each
atypical form will be grouped separately.
Background summary
Patients with atypical forms of parkinsonism are challenging to distinguish
from Parkinson patients in the clinical workflow. Novel quantitative MRI
techniques demonstrated differential diagnosis at a late-stage of disease. It
is unknown how valuable such techniques are at an early-stage of the disease.
Study objective
Primary Objective: To investigate whether a quantitative MRI protocol can
detect the difference between atypical parkinsonism and patients with
Parkinson*s disease, in an early phase of the diseases when the clinical
diagnosis for either is not yet certain.
Secondary Objective(s):
1. To investigate differences in the primary outcomes between patients with
possible Parkinson*s disease, MSA-C, MSA-P and PSP.
2. To investigate the differences among early-stage, possible PD patients and
near-certain PD patients.
3. To calculate the sensitivity and specificity of differential diagnoses using
the differences in the primary objective as well as the first and second
secondary objectives, and compare those to current published results for
late-stage patients.
Study design
Observational pilot study
Study burden and risks
Patient participants in this study whom are already eligible for an MRI scan,
will be burdened with additional MRI scan-time of 15-20 minutes. Patient
participants who are not eligible for an MRI scan will be burdened with a new
MRI scan of 45 minutes. Both will receive a physical follow up health check,
which will take place approximately and at a maximum 1 year after the MRI,
during their control visits.
Healthy volunteers will be burdened with an MRI scan of 40-45 minutes and a 1
year follow-up with a phone call.
Patients participating in this study will not receive a benefit, in the form of
an improved clinical treatment. The MRI scan is harmless as there is no use of
ionizing radiation. However, they have to lie in a narrow bore for the
examination which is not suitable for people with claustrophobia. The MRI scan
is also loud and requires wearing ear-plugs. Volunteers participating in this
study will experience the same burdens, however in addition the MRI was not
required in the first place.
Both participant groups will be exposed to incidental findings, unrelated to
parkinsonism. Any consequent health care fees are for the responsibility of the
participants.
Patient participants will required to undergo a neurofilament test from their
blood. Blood is typically already drawn from these patients on routine visits
and no additional blood tests are needed. However in the case no blood has been
taken, patients will be burdened with a new blood test. Additional blood tests
are inconvenient.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Patients:
- Patients who present at the outpatient clinic of the department of neurology
with symptoms consistent with degenerative parkinsonism.
- For possible PD patients: Diagnosis of Parkinson*s disease is unclear and an
atypical form of parkinsonism is suspected.
- For near-certain PD patients: Patients for whom Parkinson*s disease is highly
suspected.
- At least 50 years old
- Signed informed consent.
Healthy volunteers:
- Healthy subject (defined as a volunteer without and signs or symptoms of
disease)
- At least 50 years old and not older than 75
- Signed informed consent
Exclusion criteria
- Patients with parkinsonism symptoms caused by medication or essential
tremors.
In addition, both patients and healthy volunteers are excluded if they meet any
of the following criteria:
- a history of another neurodegenerative disease.
- History of significant intracranial disease
- Contra-indication to an MRI exam
- Metal implants
- Women who are pregnant or lactating
- Having any physical or mental status that interferes with the informed
consent procedure
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 | NL78601.078.21 |