Parkinson DiseaseNCT01715727
Diagnosis of Parkinson's Disease Using Diffusion Magnetic Resonance Imaging
An observational study of Parkinson Disease, run by Wang . Jiun-Jie at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 284 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Parkinsons"s Disease for follow up: 112 subjects
- 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.
- Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
- 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
- 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.
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- Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
- 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):
- PSP Patients should fulfill the NINDS-SPSP and Litvan criteria(4) for probable PSP
- Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
- Able to understand and provide signed informed consent.
Who cannot join
- The following exclusion criteria apply to all groups.
- Cardiac pacemaker implantation.
- Implantation of intracranial metal device.
- Significant major systemic disease, such as renal failure, heart failure, stroke, AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
- Pregnant or breast feeding women.
- Moderate to severer dementia.
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- Severe dyskinesia
- 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.
- History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- Significant physical disorder or neuropsychiatric disorder.
- Except the medication for parkinsonism and related symptoms, subjects who received any medication that can pass the blood-brain barrier will be excluded.
- Except the medication for parkinsonism and related symptoms, subjects who chronically take any drug for more than 10 years will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Keywords
- diffusion kurtosis imaging, parkinson disease, parkinsonism, diagnosis, differential diagnosis
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
differential diagnosis
To differentiate patient of PD from PD + using diffusion MRI
Measured: end of the second year
Secondary outcomes (1)
prognosis
To predict the outcome of patient with PD using the diffusion MRI at baseline
Measured: end of the third year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wang . Jiun-Jie
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor-investigator, Wang . Jiun-Jie, Chang Gung Memorial Hospital
- Investigators
- Jiun-Jie Wang, PhD, Principal investigator, ChangGung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715727
- Sponsor's protocol ID
- 100-3761A3
- Status last verified
- Aug 2016
- First submitted
- 25 Oct 2012
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang JJ, Lin WY, Lu CS, Weng YH, Ng SH, Wang CH, Liu HL, Hsieh RH, Wan YL, Wai YY. Parkinson disease: diagnostic utility of diffusion kurtosis imaging. Radiology. 2011 Oct;261(1):210-7. doi: 10.1148/radiol.11102277. Epub 2011 Jul 19.
PubMed 21771952
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Parkinson's Disease Using Diffusion Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01715727
- Acronym / sponsor ID
- 100-3761A3
- Conditions
- Parkinson Disease
- Keywords
- diffusion kurtosis imaging, parkinson disease, parkinsonism, diagnosis, differential diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Wang . Jiun-JieUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jul 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Parkinsons"s Disease for follow up: 112 subjects
- 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.
- Able to tolerate the disability during the "drug-off" state, at least for 12 hours.
- 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
Key exclusion criteria (12 listed)
- The following exclusion criteria apply to all groups.
- Cardiac pacemaker implantation.
- Implantation of intracranial metal device.
- Significant major systemic disease, such as renal failure, heart failure, stroke, AMI/unstable angina, poor controlled diabetes mellitus, poor controlled hypertension.
- Pregnant or breast feeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
differential diagnosis
Time frame: end of the second year
To differentiate patient of PD from PD + using diffusion MRI
1 secondary outcome
prognosis
Time frame: end of the third year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Background: PubMed 21771952Wang JJ, Lin WY, Lu CS, Weng YH, Ng SH, Wang CH, Liu HL, Hsieh RH, Wan YL, Wai YY. Parkinson disease: diagnostic utility of diffusion kurtosis imaging. Radiology. 2011 Oct;261(1):210-7. doi: 10.1148/radiol.11102277. Epub 2011 Jul 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiun-Jie Wang, PhD principal investigator
ChangGung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Wang . Jiun-Jie at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differential diagnosis (time frame: end of the second year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01715727, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.