Status:
COMPLETED
Imaging Biomarkers in Parkinson s Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-100 years
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 full...
Detailed Description
Objectives: The purpose of this protocol is to evaluate possible imaging biomarkers for diagnosis and assessment of disease progression in Parkinson disease (PD) through multi-modal neuroimaging stud...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 24 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01496599
Start Date
January 24 2012
Last Update
December 24 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892