Status:
WITHDRAWN
Attentional Performance in Parkinson Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson's Disease
Eligibility:
All Genders
35-80 years
Brief Summary
Background: Parkinson Disease (PD) is a nervous system disorder that affects movement. Dopamine is an important neurotransmitter in the brain. As PD progresses, there is less and less dopamine in the...
Detailed Description
Study Description: We will investigate the relationship between Dopamine (DA) function and attention in patients with asymmetric Parkinson Disease (PD). We hypothesize that the direction of asymmetry...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female aged 35 - 80 (inclusive)
- Fluent in English
- Right-handed per the Edinburgh Handedness scale
- Able to provide consent
- Diagnosis of idiopathic Parkinson s disease according to UK Brain Bank criteria
- On dopaminergic therapy to treat Parkinsonian symptoms
- MOCA Score greater than or equal to 24 determined by a NIH neurologist
- Hoehn and Yahr Score less than or equal to 3 determined by a NIH neurologist
- Asymmetric motor symptoms
- EXCLUSION CRITERIA:
- Any current major neurological or psychiatric disorder other than Parkinson s disease, such as, (but not limited to) stroke, dementia, Alzheimer disease, Schizophrenia or Major Depression Disorder
- Inability to provide consent
- Members of the Behavioral Neurology Unit, NINDS
- Left-handed per the Edinburgh Handedness scale
- Primarily axial motor symptoms or symmetrical limb involvement
- Pregnancy
- Exclusion criteria for MRI
- Presence of metal which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if subject was a welder or metal worker, since small metal fragments may be present in the eye.
- Claustrophobia
- Inability to lie supine comfortably for 1 hour
- Pregnancy
- INCLUSION OF VULNERABLE PARTICIPANTS:
- Because the goals of the study can be accomplished without involving vulnerable population, we will not include individuals without consent capacity.
- Since the goal is to characterize visuospatial attention deficits in idiopathic PD which is a disease of late adulthood, we will not include children.
- The effects of MRI on fetal development and the health of pregnant women is unknown.
- Therefore, women who are pregnant and breast-feeding will be excluded and women who can become pregnant will be excluded following a positive pregnancy test, if the optional MRI is under consideration.
- The study requires fluency in English in order to completely understand tasks instructions, thus non-English speakers/readers will be excluded.
Exclusion
Key Trial Info
Start Date :
December 6 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04428931
Start Date
December 6 2021
End Date
December 6 2021
Last Update
December 10 2021
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892