Diagnosis of Parkinson's Disease Using Diffusion Magnetic Resonance Imaging
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from the movement disorder clinics in ChangGung memorial
        hospital LinKou. The healthy control will be recruited from the local community in northern
        Taiwan.
      
Keywords: diffusion kurtosis imaging; parkinson disease; parkinsonism; diagnosis; differential diagnosis