Imaging Biomarkers in Parkinson s Disease
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|ClinicalTrials.gov Identifier: NCT01496599|
Recruitment Status : Recruiting
First Posted : December 21, 2011
Last Update Posted : July 27, 2020
- Parkinson s disease (PD) causes slow movement, stiffness, and tremor. It results from the loss of a brain chemical called dopamine. PD gets worse over time, but researchers do not fully understand why the brain cells that produce dopamine stop working or die in people with PD. This study will use different ways of imaging the brain and brain chemicals to look at PD. It will compare brain imaging in people who definitely have PD to people who might have PD and to people without signs of PD. It will provide more information how the brain in people with PD changes over time.
- To understand the changes that occur in the brains of people with Parkinson s disease.
- Individuals at least 18 years of age who have definite or possible Parkinson s disease.
- Healthy volunteers at least 18 years of age.
- Participants will have a screening visit with a physical exam and medical history.
- Participants will visit the National Institutes of Health Clinical Center every 18 month or 3 years for up to 9 years. There will be up to 6 total visits. Most visits will last 5 to 6 hours a day for 1 to 3 days.
Some or all of the following tests will be performed at each visit:
- Magnetic resonance imaging to take pictures of the brain. Some of these tests will be done at rest. Others will require participants to perform an activity during the scan.
- Medication withdrawal for 12 hours overnight for people taking PD medications. This may be done before some scans. Participants who feel unwell when they stop taking medications will be allowed to start taking them again.
- Participants will continue with the follow up visits until the end of the study.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||114 participants|
|Official Title:||Imaging Biomarkers in Parkinson Disease|
|Actual Study Start Date :||January 24, 2012|
Subjects without PD diagnosis
Parkinsons Disease subjects
Subjects fitting the MSD Clinical Diagnostic Criteria for PD
Prodromal Parkinson disease
Subjects fitting the MDS prodromal criteria for PD
- Using MRI, we will measure signal intensities of iron-rich structures using T2 sequences and calculate phase shift values in these structures with susceptibility weighted sequences. We will also measure clinical symptom severity with the UPDR sc... [ Time Frame: 10 years ]-Structural MRI (SWI images): The primary outcome measure is the difference in susceptibility changes in iron-rich structures (ie. The SN, red nucleus, striatum) across groups and within groups over time.-Clinical presentation: We will evaluate how the prodromal symptoms influence the progression to clinical PD.
- Structural MR (Morphometry and diffusion analyses) [ Time Frame: 10 years ]The outcome measures are the differences in gray and white matter morphometry across groups and within groups over time. We will derive measures such as fractional anisotropy, trace, and parenchymal volume fractions as measures of fiber tract integrity, across groups and within groups over time.
- fMRI [ Time Frame: 10 years ]The outcome measure for fMRI is the difference in resting state functional connectivity patterns as reflected by BOLD signal fluctuations and their dynamics across groups and over time.
- MRS [ Time Frame: 10 years ]The outcome measure for MRS is the difference in the spectroscopy signal amplitude of phosphorus- containing compounds and neurotransmitters in the sensorimotor cortices and basal ganglia across groups and over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496599
|Contact: Myriam E Martinez Vega, R.N.||(301) firstname.lastname@example.org|
|Contact: Silvina G Horovitz, Ph.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Silvina G Horovitz, Ph.D.||National Institute of Neurological Disorders and Stroke (NINDS)|