Diagnosis of Parkinson's Disease Using Diffusion Magnetic Resonance Imaging

NCT01715727 | Completed DMC

• 1 other identifier: 100-3761A3
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

diffusion kurtosis imaging; parkinson disease; parkinsonism; diagnosis; differential diagnosis

Outcome Measures

Primary Outcomes (1)

• differential diagnosis

  To differentiate patient of PD from PD + using diffusion MRI

  end of the second year

Secondary Outcomes (1)

• prognosis

  end of the third year

Study Arms (5)

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.

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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 ):
• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Wang . Jiun-Jie: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

ChangGung Memorial Hospital, Linkou

Taoyuan, Taiwan, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 21771952 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiun-Jie Wang, PhD

  ChangGung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

TW (1)