Status:
COMPLETED
Imaging Studies of Cognitive Impairment in Parkinson s Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Dementia
Eligibility:
All Genders
40+ years
Brief Summary
Background: \- Parkinson's disease causes slow movements, stiffness, and tremor. It can get worse over time, and in some cases can lead to dementia. Researchers are interested in how dementia affects...
Detailed Description
Objectives: The purpose of this protocol is to identify the neural correlates of cognitive impairment in Parkinson disease (PD) using magnetic resonance imaging (MRI). Study Population: We will st...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- For all subjects:
- Age 40 or older.
- Able to abstain from caffeine and alcohol for 24 hours before each visit.
- English is the first language.
- Right handed
- For PD cohort:
- Established diagnosis of PD.
- History compatible with diagnosis of PD
- Present with at least 3 of the following features: bradykinesia, resting tremor, cogwheel rigidity or postural reflex impairment
- One of the 3 clinical features is either bradykinesia or resting tremor
- Currently taking or history of taking dopaminergic therapy with symptomatic response.
- Is able to give informed consent or, if there is evidence of cognitive decline, able to give assent and able to appoint a durable power of attorney (DPA) who can give informed consent.
- EXCLUSION CRITERIA for all subjects:
- Use of illegal drugs within the past 6 months.
- 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, epilepsy or a history of seizures, except PD for PD patients.
- 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.
- Inability to lie flat on the back for up to 2 hours.
- Claustrophobia or a feeling of discomfort from being in small, enclosed spaces of enough severity to prevent MRI scanning.
- 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 medications or substances within 6 months of getting MRI scan: e.g., Cocaine, amphetamines, methylphenidate, ephedrine, phentermine, buproprion, fentanyl, ketamine, and phencyclidine. Prescribed medication for common conditions, such as allergy or cold, will not be exclusionary. Prescribed medication for PD will not be exclusionary for PD patient.
- Have uncontrolled head movements that may impair image data collection (for PD patients).
- Subjects with MMSE\<26 for HVs.
- Have clinically relevant focal neurological findings on exam that suggest cerebral pathology other than that associated with PD for PD patients.
- Any abnormal or focal finding on neurological exam for HVs.
- Abnormal findings in clinical MRI.
- PD patients with Beck Depression Inventory (BDI)-II \> 31 will be excluded, because severe or extreme depression may confound with cognitive function.
Exclusion
Key Trial Info
Start Date :
April 4 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 3 2015
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01862744
Start Date
April 4 2013
End Date
February 3 2015
Last Update
December 12 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892