Diagnosis of Parkinson's Disease Using Diffusion Magnetic Resonance Imaging

August 3, 2016 updated by: Wang . Jiun-Jie

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

284

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • TaoYuan county, Taiwan, 333
        • ChangGung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

Parkinsons"s Disease for follow up: 112 subjects

  1. Patients should fulfill the National Institute of Neurological Disorders and Stroke in USA ( NINDS ) Diagnostic Criteria for Parkinson Disease(37) for "probable" PD, except for the age of onset.
  2. Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
  3. Able to understand and provide signed informed consent. 4. Early to moderate stage defined as Hohen and Yahr stage 1-3, subjects = 100

Parkinsons"s Disease with severity match: 30 subjects

  1. Patients should fulfill the National Institute of Neurological Disorders and Stroke in USA ( NINDS ) Diagnostic Criteria for Parkinson Disease(37) for "probable" PD, except for the age of onset.
  2. Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
  3. Able to understand and provide signed informed consent. 4. Severity matched with PSP (subjects = 15)/MSA (subjects= 15), the severity was judged by Hohen and Yahr stage

Healthy age matched controls: subjects = 112 1. Healthy subjects without a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness. 2. Able to understand and provide signed informed consent. 3. Age range and gender matched with Parkinsons"s Disease for follow up.

Parkinson Plus Syndrome Group M ( Multi System Atrophy, subjects = 15 ):

1. MSA Patients should fulfill the NINDS Consensus statement for the clinical diagnosis of probable MSA(38) 2. Able to tolerate the disability during the "drug-off" state, at least for 12 hours. 3. Able to understand and provide signed informed consent 2012/04/20 第二版 14

Parkinson Plus Syndrome Group P (Progressive Supranuclear Palsy, subjects = 15):

  1. PSP Patients should fulfill the NINDS-SPSP and Litvan criteria(4) for probable PSP
  2. Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
  3. Able to understand and provide signed informed consent.

Exclusion Criteria:

The following exclusion criteria apply to all groups.

  1. Cardiac pacemaker implantation.
  2. Implantation of intracranial metal device.
  3. Significant major systemic disease, such as renal failure, heart failure, stroke, AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
  4. Pregnant or breast feeding women.
  5. Moderate to severer dementia.
  6. Severe dyskinesia
  7. Any documented abnormality of brain in the brain by MRI and 18FDG PET studies, which might contribute to the cognitive function, such as hydrocephalus or encephalomalacia, will be excluded. Mild cortical atrophy will be allowed.
  8. History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
  9. Significant physical disorder or neuropsychiatric disorder.
  10. Except the medication for parkinsonism and related symptoms, subjects who received any medication that can pass the blood-brain barrier will be excluded.
  11. Except the medication for parkinsonism and related symptoms, subjects who chronically take any drug for more than 10 years will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Parkinson's Disease for follow-up
  1. Patients should fulfill the National Institute of Neurological Disorders and Stroke in USA ( NINDS ) Diagnostic Criteria for Parkinson Disease(37) for "probable" PD, except for the age of onset.
  2. Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
  3. Able to understand and provide signed informed consent.
  4. Early to moderate stage defined as Hohen and Yahr stage 1-3,
Parkinsons"s Disease with severity match

Parkinsons"s Disease with severity match: 30 subjects

  1. Patients should fulfill the National Institute of Neurological Disorders and Stroke in USA ( NINDS ) Diagnostic Criteria for Parkinson Disease(37) for "probable" PD, except for the age of onset.
  2. Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
  3. Able to understand and provide signed informed consent.
  4. Severity matched with PSP (subjects = 15)/MSA (subjects= 15), the severity was judged by Hohen and Yahr stage
Healthy age matched controls

Healthy age matched controls: subjects = 112

  1. Healthy subjects without a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
  2. Able to understand and provide signed informed consent.
  3. Age range and gender matched with Parkinsons"s Disease for follow up.
Parkinson Plus Syndrome Group M
  1. MSA Patients should fulfill the NINDS Consensus statement for the clinical diagnosis of probable MSA
  2. Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
  3. Able to understand and provide signed informed consent
Parkinson Plus Syndrome Group P
  1. PSP Patients should fulfill the NINDS-SPSP and Litvan criteria(4) for probable PSP
  2. Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
  3. Able to understand and provide signed informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differential diagnosis
Time Frame: end of the second year
To differentiate patient of PD from PD + using diffusion MRI
end of the second year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prognosis
Time Frame: end of the third year
To predict the outcome of patient with PD using the diffusion MRI at baseline
end of the third year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wang . Jiun-Jie

Collaborators

National Science Council, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 3, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100-3761A3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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