Attentional Performance in Parkinson Disease

NCT04428931 | Withdrawn

• 2 other identifiers: 20010220-N-0102
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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 brain. Researchers think there may be a relationship between differences in attention and dopamine in people with PD. Objective: To learn if people with PD that is worse on one side also have differences in how much attention they pay to the two sides of space on their left and right. Eligibility: English-speaking, right-handed people age 35-80 with PD. Design: Participants will be screened with medical and neurological history and exam, and medicine review. Participants will have 1 study visit. It will last 7-8 hours. They will stop taking their Parkinson medicine 12 hours before the visit. Participants will complete questionnaires. Participants will do tasks on a computer screen. They will judge the middle of lines, react to stimuli, and search and identify items that appear on the screen. Participants may have functional and structural magnetic resonance imaging (MRI). MRI uses a strong magnetic field and radio waves to take pictures of the brain. During the MRI, participants will lie on a table that slides in and out of the MRI scanner. While inside the scanner, they will look at a cross on a screen, relax, and think about nothing. Participants will undergo prism adaptation. They will sit in front of a board while their chin rests on a support. They will point to 1 of 2 dots on the board while they wear prism glasses that shift their vision to the left or right....

Conditions

Parkinson's Disease

Keywords

Functional Connectivity; Visual Attention; Dopamine Depletion; Landmark Test

Outcome Measures

Primary Outcomes (1)

• Attentional asymmetry

  Direction and degree of visuospatial bias on the Landmark task

  2 months

Secondary Outcomes (1)

• Feedback learning and visuospatial attention performance

  2 months

Study Arms (1)

PD patients

Patients with Asymmetric Parkinson's disease

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asymmetric PD patients

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Eric M Wassermann, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 11, 2020
• Study Start: December 6, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

US (1)