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Imaging Biomarkers in Parkinson s Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01496599
Recruitment Status : Recruiting
First Posted : December 21, 2011
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

Background:

- 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.

Objectives:

- To understand the changes that occur in the brains of people with Parkinson s disease.

Eligibility:

  • Individuals at least 18 years of age who have definite or possible Parkinson s disease.
  • Healthy volunteers at least 18 years of age.

Design:

  • 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
Parkinson Disease

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 114 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Imaging Biomarkers in Parkinson Disease
Actual Study Start Date : January 24, 2012

Resource links provided by the National Library of Medicine


Group/Cohort
Healthy Volunteers
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Part 1 (Case-control study): We will study 30 patients with well-defined PD, as defined by the UK Parkinson s Society Brain Bank diagnostic criteria (Hughes et al., 1992, Olanow et al., 2009, Defer et al., 1999). We will also study 15 age-matched healthy volunteers (HVs) as controls.Part 2 (Longitudinal study): We will continue to study subjects from Part 1 periodically over the following 9 years. We will also study 30 subjects with early parkinsonism (EP). EP subjects are defined as individuals who have experienced at least one but fewer than 3 of the cardinal symptoms of PD at the time of enrollment.
Criteria
  • INCLUSION CRITERIA:

For all subjects:

  • Age 18 or older.
  • Subjects must fulfill either the clinically defined PD, prodromal PD or not having any of the red flags following the MDS criteria for PD.
  • Able to give informed consent or, if there is evidence of cognitive decline, able to appoint a durable power of attorney (DPA) who can give informed consent.

EXCLUSION CRITERIA:

  • More than 7 alcoholic drinks a week for females or 14 alcoholic drinks a week for males.
  • History of a neurologic disorder such as a brain tumor, stroke, central nervous system infection, multiple sclerosis, a movement disorder other than the ones under study, epilepsy or a history of seizures or any abnormal or focal finding on neurological exam other than that associated with those studied in this protocol.
  • History of any head injury with loss of consciousness
  • Pregnancy or positive pregnancy test before the research procedure due to the risks associated with MRI scans. This would exclude subjects from participating in the protocol at that time.
  • Inability to lie flat on the back for up to 2 hours
  • Claustrophobia or a feeling of discomfort from being in small, enclosed spaces.
  • Surgically or traumatically implanted metallic foreign bodies, such as pacemakers, implanted medical pumps, implanted hearing aids, metal plates in the skull or metal implants in the skull or eyes (other than dental fillings) that may be physically hazardous during an MRI, or might distort the images.
  • Ablative surgery or implanted electrodes and generator for deep brain stimulation
  • Use of the following therapies which may affect mitochondrial function: Coenzyme Q10, vitamin E, vitamin C, anti-retroviral drugs, chemotherapeutic agents, anti-epileptics agents or antibiotics. (Use ofthese substances will prevent getting MRS scan only).
  • Have uncontrolled head movements that may impair image data collection

Information from the National Library of Medicine

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


Contacts
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Contact: Myriam E Martinez Vega, R.N. (301) 496-9526 myriam.martinez@nih.gov
Contact: Silvina G Horovitz, Ph.D. (301) 435-2163 silvina.horovitz@nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Silvina G Horovitz, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)
Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT01496599    
Other Study ID Numbers: 120031
12-N-0031
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 21, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Brain Imaging
Parkinson's Disease
Parkinsonism
Parkinson Disease
PD
Healthy Volunteer
HV
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases