Attentional Performance in Parkinson Disease

  • STATUS
    Recruiting
  • End date
    Mar 4, 2030
  • participants needed
    60
  • sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
Updated on 19 February 2024
dopamine
MRI
parkinson's disease
parkinsonism
nervousness
motor symptoms
attention deficit
nervous system disorder
neurologic findings

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....

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 in dopamine (DA) depletion predicts the asymmetry in visual attention.

Objectives

Primary Objective:

  • to study attentional asymmetry in patients with PD. We hypothesize that visual attention in Parkinson will be biased to the visual field contralateral to the least affected hemisphere (i.e. contralateral to the most affected side).

Secondary Objectives:

  • to investigate the correlation between feedback learning and visuospatial attention performance in PD. We hypothesize that feedback learning will also be affected according to the most compromised hemisphere. Right hemisphere-predominant PD patients (left-motor predominant), compared to left hemisphere-predominant patients, will exhibit a rightward visuospatial bias and a relative preference for learning from reward, compared to punishment.
  • to investigate the effect of prism adaptation on feedback learning and visuospatial attention in PD. This objective is exploratory.
    Endpoints

Primary Endpoint: visuospatial performance on the Landmark Task

Secondary Endpoints: performance on:

  • Posner Task
  • Visual Search Task
  • Attentional blink Task
  • Visuospatial performance on the Manual Line Bisection Task
  • Reward and Punishment Implicit Feedback Learning Task
  • The Attentional Scaling Task

Functional connectivity measured with resting state fMRI.

Study Population:

Sixty patients with asymmetric PD. Any gender, aged 35-80 (inclusive), able to give consent and without a diagnosis of significant illness affecting the central nervous system other than PD.

Details
Condition Parkinson's Disease, Parkinson's Disease
Age 35-80 years
Clinical Study IdentifierNCT04428931
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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