Diagnosis of Parkinson's Disease Using Diffusion Magnetic Resonance Imaging
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|ClinicalTrials.gov Identifier: NCT01715727|
Recruitment Status : Completed
First Posted : October 29, 2012
Last Update Posted : August 4, 2016
The hypothesis of the study is that the dopaminergic cell death located in the basal ganglia of the brain in patients with Parkinson's Disease can be detected by diffusion Magnetic Resonance Imaging, specifically by diffusion kurtosis imaging. The preliminary result was published in Radiology 2011. The current study proposed to investigate the following issues:
- validation of diagnostic sensitivity and specificity
- differential diagnosis capability between PD and PD+ syndrome
- prognosis capability
In the first year, patients with Parkinson's disease will be recruited from the outpatient clinics of movement disorders in ChangGung memorial hospital Linkou, Taiwan. The diffusion parameters in basal ganglia will be compared with a group of healthy controls. In the second year, patients with progressive supranuclear palsy and patients with multiple system atrophy will be recruited for assessment of differential diagnosis. The patients with Parkinson's Disease will return for assessment of disease severity and in the third year, for the outcome evaluation.
|Condition or disease|
Currently there existed no specific diagnostic test of Parkinson's Disease. Accurate diagnosis is of great interest because of the reduction in health cost and disease co-morbidity, improvement in effective treatment course and avoidance of un-necessary intervention. Our preliminary result showed superior performance from diffusion kurtosis imaging, a new development in MRI since 2007, on the diagnosis of Parkinson's Disease when compared to conventional diffusion MRI. The study proposes to validate the diagnostic value of diffusion kurtosis in major basal ganglia regions using a cross-sectional study and to assess the prognostic value through 3-year longitudinal follow-up. Furthermore, the iron content as well as global white matter involvement in both PD and PD plus syndrome patients will be assessed. The difference in MRI information between PD and PD plus syndrome patients will then be addressed in a comprehensive manner.
One hundred and twelve patients with Parkinson's Disease will be recruited in the first year and followed up for 3 years. Another 112 healthy controls will be included. This is to validate the diagnosis and assess the prognosis. Another 30 patients with Parkinson's Disease, 15 patients with progressive supranuclear palsy and 15 patients with multiple system atrophy will be recruited in the 2nd year for differential diagnosis. The imaging protocol will include both diffusion tensor and diffusion kurtosis imaging. Susceptibility weighted imaging will be included for iron content estimation. The targeted anatomy will include regional changes in basal ganglia, midbrain as well as thalamus, and global white matter changes using tract based spatial statistics. The statistical analysis will use receiver operative characteristics to assess the diagnostic performance, Spearman's ranked correlation for correlation with disease severity and net reclassification improvement for differential diagnosis. The prognostic value will be determined by the decline rate and the quality of life.
The end points of the project are to differentiate patients of PD from PD plus syndrome, and to predict the clinical outcomes using diffusion MRI. Patent application will be filed in the first year. The analysis of medical device software and software life cycle processes and the evaluation of risk management to medical devices will be filed at the end of the third year.
|Study Type :||Observational|
|Actual Enrollment :||284 participants|
|Observational Model:||Case Control|
|Official Title:||Diagnosis of Parkinson's Disease Using Diffusion Magnetic Resonance Imaging|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Parkinson's Disease for follow-up
Parkinsons‟s Disease with severity match
Parkinsons‟s Disease with severity match: 30 subjects
Healthy age matched controls
Healthy age matched controls: subjects = 112
Parkinson Plus Syndrome Group M
Parkinson Plus Syndrome Group P
- differential diagnosis [ Time Frame: end of the second year ]To differentiate patient of PD from PD + using diffusion MRI
- prognosis [ Time Frame: end of the third year ]To predict the outcome of patient with PD using the diffusion MRI at baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01715727
|ChangGung Memorial Hospital, Linkou|
|TaoYuan county, Taiwan, 333|
|Principal Investigator:||Jiun-Jie Wang, PhD||ChangGung University|