Status:
COMPLETED
Identifying Biomarkers of Parkinson's Disease Using Magnetic Resonance Imaging (MRI)
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Parkinson's Disease (PD)
Parkinsonism
Eligibility:
All Genders
21-90 years
Brief Summary
This study is designed to determine if magnetic resonance imaging (MRI) measures can be used to diagnose and monitor the progression of Parkinson's disease (PD) while distinguishing between PD and par...
Detailed Description
The lack of in vivo biomarker(s) reflecting Parkinson's disease (PD)-related cell loss and associated pathoetiological/physiological processes in nigrostriatal structures has hindered discovery resear...
Eligibility Criteria
Inclusion
- PD Subjects:
- Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.
- MMSE score of 15 or greater unless a legal representative is present.
- Idiopathic PD according to published criteria.
- History of adequate response to dopaminergic therapy.
- History of asymmetrical symptom onset
- MSA Subjects:
- Older than 30 yrs.
- Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.
- MMSE score of 15 or greater unless a legal representative is present.
- MSA according to published criteria.
- History of autonomic \& urinary dysfunction and/or severe cerebellar ataxia.
- PSP Subjects:
- Older than 40 yrs.
- Able and willing to sign the consent form at time of initial enrollment or if the subject is decisionally impaired and has a legal representative that is able and willing to sign a consent form at the time of the enrollment. If the subject becomes decisionally impaired during the course of the study, their legal representative may sign an addendum to consent for continued participation.
- PSP according to published criteria.
- Vertical gaze palsy and/or slow vertical gaze/postural instability during first year of diagnosis.
- MMSE score of 15 or greater unless a legal representative is present
- Controls:
- Older than 21 yrs.
- Able and willing to sign the consent form.
- MMSE greater than 24.
Exclusion
- PD Subjects:
- Unable or does not have a legal representative/unwilling to provide consent.
- Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
- History of cerebrovascular diseases or other neurological disorders.
- Major medical problems such as renal or liver failure.
- Unstable, non-PD-related medical conditions.
- MMSE score less than 15 unless a legal representative is present
- Use of anticoagulant medications.
- Signs of dementia.
- MSA Subjects:
- Unable or does not have a legal representative /unwilling to provide consent.
- Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
- History of cerebrovascular diseases or other neurological disorders.
- Major medical problems such as renal or liver failure.
- Unstable, non-MSA-related medical conditions.
- MMSE score less than 15 unless a legal representative is present
- Use of anticoagulant medications.
- Signs of dementia.
- PSP Subjects:
- Unable or does not have a legal representative /unwilling to provide consent.
- Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
- History of cerebrovascular diseases or other neurological disorders.
- Major medical problems such as renal or liver failure.
- Unstable, non-PSP-related medical conditions.
- MMSE score less than 15 unless a legal representative is present
- Use of anticoagulant medications.
- Signs of dementia.
- Controls:
- Unable/unwilling to provide consent.
- Evidence of severe memory impairment or signs of dementia (MMSE \< 24).
- Any condition that precludes a routine MRI (e.g., claustrophobia, pacemaker, severe scoliosis, etc.).
- History of cerebrovascular diseases or other neurological disorders.
- Major medical problems such as renal or liver failure.
- Unstable medical conditions.
- Use of anticoagulant medications.
- Signs of dementia.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01888185
Start Date
December 1 2012
End Date
December 31 2019
Last Update
January 3 2020
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center and College of Medicine
Hershey, Pennsylvania, United States, 17033