Parkinson's Disease Clinical Trial
Official title:
Diagnostic Value Transcranial Duplex Scanning and Single Photon Emission Tomography in Patients Suspected of Having Idiopathic Parkinson Disease or Atypical Parkinson Syndromes
The purpose of the study is to determine the sensitivity and specificity of transcranial duplex scanning (TCD) and single photon emission computer tomography (SPECT) in patients suspected of having Idiopathic Parkinson Disease (PD) or Atypical Parkinson Syndromes (APS) with as golden standard the clinical diagnosis after 2-year follow-up.
PD is a progressive neurodegenerative illness that affects about 50.000 people in the
Netherlands. Diagnosis is based on clinical criteria. However, purely on clinical grounds,
especially in the early stage, it is not possible to differentiate PD from other parkinsonian
syndromes like multiple system atrophy, Progressive Supranuclear Palsy, vascular
parkinsonism, drug induced parkinsonism and essential tremor. Accurate differentiation is
important because treatment and prognosis varies between the different syndromes.
At present SPECT scans are used mostly. However the SPECT is only used in the minority of the
patients suspected of PD mainly because the costs and the discussion about their sensitivity
and specificity to diagnose PD. We are currently finishing a meta-analysis on the diagnostic
value of the SPECT in patients with parkinsonian diseases.
Recently an alternative method to visualise the alterations in the cerebral dopaminergic
pathways of PD patients has been proposed: TCD of the substantia nigra in the brainstem. This
technique has high inter-observer reliability. Becker discovered in 1994 that patients with
PD had bilateral hyperechogenicity of the substantia nigra. Neuropathological studies confirm
the increased echogenicity is because of iron deposition. However the reason of the increased
level of iron is unknown.
Several publications confirm the observation that up to 90% of PD patients have increased
echogenicity of the substantia nigra. In healthy subjects and in patients with essential
tremor this hyperintensity of the substantia nigra is only found in 10%. However 60% of the
healthy subjects with increased echogenicity also have decreased nigra-striatal function on
(18)-F-dopa-PET. So TCD might possibly be an early (presymptomatic) marker for PD.
If substantia nigra scanning is combined with scanning of the nucleus lentiformis, the
differentiation between PD and APS is increased. Another advantage is that with the same
technique the raphe nuclei can be made visible. Several studies confirm the echogenicity of
raphe nuclei is decreased in PD patients with a depression.
Our own experience suggests that the positive predictive value of this technique nears that
of SPECT scans. In our pilot study with 45 patients with PD or APS who underwent SPECT and
TCS we found a positive prediction value of 95%. This would predict that, if TCE is
compatible with PD, a SPECT does not provide additional information; so in theory one might
reduce the amount of SPECT's in almost 50% of cases.
A direct compare of the diagnostic accuracy as to PD between duplex and SPECT scans has until
now not been made. Our hypothesis is that the TCD of substantia nigra duplex scanning is an
accurate diagnostic tool and deserves a place in the diagnostic work-up of PD/Parkinsonism
patients and diagnostically efficient enough to replace 50% of SPECT scans. In comparison
with SPECT duplex scanning is less costly (respectively 80 euro and 400 euro for each SPECT)
and more comfortable for the patient.
Methods:
Subjects:
250 consecutive patients with new parkinsonian complaints in the out-patient clinic of our
university hospital (Maastricht) and a local hospital.
Study design:
The investigator will give a clinical diagnosis at the first visit. All subjects undergo
SPECT and duplex scanning, both tests will be judged blindly for the clinical diagnosis.
After two years follow-up, all patients will be seen by the investigator and again a clinical
diagnosis will be made (investigator is blinded for the results of the duplex and SPECT). At
the end of the follow-up the sensitivity and specificity of the first clinical judgement,
duplex and SPECT can be calculated. The golden standard is the clinical diagnosis at the end
of the follow-up.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
Completed |
NCT02939391 -
A Study of KW-6356 in Subjects With Early Parkinson's Disease
|
Phase 2 | |
Completed |
NCT02927691 -
Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial
|
Phase 2 |